concentrate at the push of a button 45 6 し...

2
!"# $%&'(%(') *"# A d STOMIZED ERSONALIZED MEDICINE per patient using a blood mizable PY red Aspirate Concentrate Deliver e & Cost-Effective p to three nt using a bility to and FDA Cleared for Orthopedic Applications Processed marrow and blood can be mixed wit allograft or autograft o biology Automation Ensures Quality Fully-automated, closed system concentrates more consistently than manual systems potential actor by ut and desired umes C De 血液採分離・濃縮 抽出 MAGELLANシステムは、独自の最先端技術を応用 し、カスタマイズされた多血小板血漿-PRP (Platelet Rich Plasma)を迅速かつ簡単なボタン 操作で採取する遠心分離システムです。 完全自動処理システム 抗凝固血液の送血・遠心分離・濃縮・抽出・回収を全自動で行い ます。簡単なセットアップ、シンプルなボタン操作により処理時 間を大幅に短縮することができます。 クローズドシステム 無菌閉鎖回路使用により、感染リスクを最大限に低減していま す。完全自動操作のクローズドシステムであることから、オペ レータによる操作ミスの発生リスクがありません。 CONCENTRATE AT THE PUSH OF A BUTTON 選択可能な抽出量・濃縮率 目的に合わせたPRPの抽出量・濃縮率を選択することができま す。また、乏血小板血漿(PPP)の分離採取等の操作オプショ ンを追加選択できます。 MAGELLAN 15 10 5 0 11 12 10 6 10 4 14 Growth Factors Post-Processing (60 mL -> 6 mL) PDGF-AB PDGF-AA PDGF-BB VEGF FGF-ц EGF TGF-ц1 60mLの抗凝固血液より抽出した6mLのPRPに含まれる成長因子 成長因子 濃縮係数 PRP含まれる成長因子 血小板は、増殖や分化、血管新生、 組織修復など、細胞プロセスに影響 を与えるさまざまな成長因子を放出 します。[1][2] 遠心分離が可能な抗凝固血液量 1サイクルの遠心分離で、30~60mL の抗凝固血液を処理できます。 抽出量の選択 3~10mLの範囲内1mL単位で抽出 量を調整できます。 可能な最大抗凝固血量 1つの分離チャンバーで、3サイクル までの分離が可能です。(同一患者) 最大180mLの抗凝固血液の分離・濃 縮が可能です。 PRP抽出量(mL) 遠心分離後の濃縮率 Reference : AMSI Source: TS-0078-182. 抽出量・濃縮率の例 60mLの抗凝固血液より3mLのPRPを 抽出した場合の濃縮率 14 12 10 8 6 4 2 0 PRP抽出・回収量 抗凝固血液量 TGF-β トランスフォーミング成長因子 PDGF 血小板由来成長因子 FGF-β 線維芽細胞成長因子 VEGF 血管内皮成長因子 EGF 上皮成長因子 血液をチャンバー内 へ送血 第1スピン 赤血球の分離 赤血球の排出 PRP・他成分の採取 [即使用可能な状態] 第2スピン 血小板・白血球層の分離濃縮 オプティカルセンサー [2] Castillo T, et al. Comparison of growth factor and platelet concentration from commercial platelet-rich plasma separation systems. The American Journal of Sports Medicine. 2011. 39(2):266-271. [1] Patel A, et al. Evaluation of autologous platelet- rich plasma for cardiac surgery: outcome analysis of 2000 patients. J Cardiothorac Surg. 2016. 11(1):62. doi: 10.1186/s13019-016-0452-9. オプティカルセンサー 内蔵された光学センサーにより自動的に分離チャンバー(閉鎖回 路内)のインターフェイス(細胞層の境界)が検知され、遠心分  離を自動的に最適化します。それぞれの分離処理パラメータを調 整し、常に一定の濃度でPRPを抽出します。

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Page 1: CONCENTRATE AT THE PUSH OF A BUTTON 45 6 し ......MAGELLANシステムは、独自の最先端技術を応用 し、カスタマイズされた多血小板血漿、他成分を迅

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

遠心分離が可能な全血液量 一度の遠心分離により30~60mLの全血液を分離・濃縮できます。

抽出量の選択 3~10mLの範囲で、1mL単位で抽出量を選択することができます。

全血液最大量 一つの閉鎖回路で、同一患者の全血液を3サイクルまで実施することができます。最大180mLの全血液を分離・濃縮することが可能です。

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

14

12

10

8

6

4

2

0

Opt

ical

Sen

sors

Every

patient h

as a unique biology w

ith in

herent v

ariabilit

y, so

you need a so

lution

that is

customize

d for e

ach patient. G

o beyond th

e standard

of care

and deliver

a personaliz

ed biologic with

the M

agella

n Auto

logous C

oncentra

tion Sys

tem.

CUSTOM

IZED A

UTOLO

GOUS THERAPY

The fully

-automate

d Mage

llan sy

stem use

s pro

prieta

ry B

ioAdaptive

technology a

nd customiza

ble conce

ntratio

n facto

rs to

yield

a tailo

red

autologo

us solutio

n for e

ach patient.

DELIVER

PERSONALIZ

ED

MEDIC

INE

CONCENTRATE A

T THE P

USH OF A

BUTTO

N

SUPERIOR TECHNO

LOGY. S

UPERIOR P

ERFORM

ANCE.

Flexible & C

ost-Effe

ctive

Proce

sses u

p to th

ree

cycles p

er patie

nt usin

g a

single ki

t, with

flexibilit

y to

proce

ss bone m

arrow and

whole blood

Closed Syste

m

Minim

al bre

aks in

steril

e

barrier p

romote

safe

ty

FDA Cleare

d for

Orth

opedic Applic

ations

Proce

ssed m

arrow and

blood can be mixe

d with

allogra

ft or a

utogra

ft

Selectable O

utput

Allows u

sers

to defin

e desired th

erapeutic

volumes (

3–10 mL per c

ycle)

BioAdaptive Pro

cess

ing™

Smart t

echnology

adjusts

proce

ssing b

ased on pati

ent

biology to

optimize

resu

lts

Fully A

utomate

d

Simple one-b

utton st

art

for e

ase of u

se

Automatio

n

Ensure

s Qualit

y

Fully-auto

mated, c

losed

syste

m conce

ntrate

s

more co

nsiste

ntly th

an

manual sys

tems

Optic

al Senso

rs

Identif

y the ce

llular f

ractio

n to elim

inate erro

r and

optimize

resu

lts

Concentrate

s up

to 14x B

aselin

e1,2

Provid

es high

conce

ntratio

ns

of plat

elets, gr

owth fa

ctors

and pro

genito

r cells

Customiza

ble

Concentratio

n

Users

determ

ine potentia

l

conce

ntratio

n facto

r by

select

ing input a

nd desired

output v

olumes

BioAdaptive Pro

cess

ing

Work

s with

optical s

ensors

to ta

ilor p

roce

ssing

paramete

rs base

d on each pat

ient’s hemat

ocrit

CUSTOM

IZE P

OTENTIAL C

ONCENTRATIO

N FACTORS

HIGH IN

PUT VO

LUMES + LOW

OUTPUT V

OLUM

ES = HIG

HEST CO

NCENTRATION1

Users

can proce

ss 3

0–60 m

L per cyc

le (up to

180 m

L per patie

nt) and

select f

inal outp

ut volume betw

een 3–10

mL per c

ycle (u

p to 3

0 mL per

patient)

to custo

mize fin

al conce

ntratio

n.

Aspira

te

Conce

ntra

te

Deliv

er

Inpu

t Bon

e M

arro

w A

spira

te

(BM

A) o

r Blo

odRe

d Blo

od C

ells

(RBC

)

Sepa

rate

d

RBCs E

xtra

cted

Buffy

Coa

t Is

Con

cent

rate

d

Outp

ut = 10 m

L

Outp

ut = 6 m

L

Outp

ut = 3 m

L

Concentration Over Baseline

Mage

llan employs

cutting-e

dge te

chnology to pro

duce a custo

mized biologic

quickly and easil

y.

Nuc

leat

ed C

ells,

Plat

elet

s & G

row

th

Fact

ors R

eady

for

Imm

edia

te U

se

!"#

$%&'(%(')

*"#

60 mL In

put

45 mL In

put

30 mL In

put

14

12

10

8

6

4

2

0

Opt

ical

Sen

sors

Every

patient h

as a unique biology w

ith in

herent v

ariabilit

y, so

you need a so

lution

that is

customize

d for e

ach patient. G

o beyond th

e standard

of care

and deliver

a personaliz

ed biologic with

the M

agella

n Auto

logous C

oncentra

tion Sys

tem.

CUSTOM

IZED A

UTOLO

GOUS THERAPY

The fully

-automate

d Mage

llan sy

stem use

s pro

prieta

ry B

ioAdaptive

technology a

nd customiza

ble conce

ntratio

n facto

rs to

yield

a tailo

red

autologo

us solutio

n for e

ach patient.

DELIVER

PERSONALIZ

ED

MEDIC

INE

CONCENTRATE A

T THE P

USH OF A

BUTTO

N

SUPERIOR TECHNO

LOGY. S

UPERIOR P

ERFORM

ANCE.

Flexible & C

ost-Effe

ctive

Proce

sses u

p to th

ree

cycles p

er patie

nt usin

g a

single ki

t, with

flexibilit

y to

proce

ss bone m

arrow and

whole blood

Closed Syste

m

Minim

al bre

aks in

steril

e

barrier p

romote

safe

ty

FDA Cleare

d for

Orth

opedic Applic

ations

Proce

ssed m

arrow and

blood can be mixe

d with

allogra

ft or a

utogra

ft

Selectable O

utput

Allows u

sers

to defin

e desired th

erapeutic

volumes (

3–10 mL per c

ycle)

BioAdaptive Pro

cess

ing™

Smart t

echnology

adjusts

proce

ssing b

ased on pati

ent

biology to

optimize

resu

lts

Fully A

utomate

d

Simple one-b

utton st

art

for e

ase of u

se

Automatio

n

Ensure

s Qualit

y

Fully-auto

mated, c

losed

syste

m conce

ntrate

s

more co

nsiste

ntly th

an

manual sys

tems

Optic

al Senso

rs

Identif

y the ce

llular f

ractio

n to elim

inate erro

r and

optimize

resu

lts

Concentrate

s up

to 14x B

aselin

e1,2

Provid

es high

conce

ntratio

ns

of plat

elets, gr

owth fa

ctors

and pro

genito

r cells

Customiza

ble

Concentratio

n

Users

determ

ine potentia

l

conce

ntratio

n facto

r by

select

ing input a

nd desired

output v

olumes

BioAdaptive Pro

cess

ing

Work

s with

optical s

ensors

to ta

ilor p

roce

ssing

paramete

rs base

d on each pat

ient’s hemat

ocrit

CUSTOM

IZE P

OTENTIAL C

ONCENTRATIO

N FACTORS

HIGH IN

PUT VO

LUMES + LOW

OUTPUT V

OLUM

ES = HIG

HEST CO

NCENTRATION1

Users

can proce

ss 3

0–60 m

L per cyc

le (up to

180 m

L per patie

nt) and

select f

inal outp

ut volume betw

een 3–10

mL per c

ycle (u

p to 3

0 mL per

patient)

to custo

mize fin

al conce

ntratio

n.

Aspira

te

Conce

ntra

te

Deliv

er

Inpu

t Bon

e M

arro

w A

spira

te

(BM

A) o

r Blo

odRe

d Blo

od C

ells

(RBC

)

Sepa

rate

d

RBCs E

xtra

cted

Buffy

Coa

t Is

Con

cent

rate

d

Outp

ut = 10 m

L

Outp

ut = 6 m

L

Outp

ut = 3 m

L

Concentration Over Baseline

Mage

llan employs

cutting-e

dge te

chnology to pro

duce a custo

mized biologic

quickly and easil

y.

Nuc

leat

ed C

ells,

Plat

elet

s & G

row

th

Fact

ors R

eady

for

Imm

edia

te U

se

!"#

$%&'(%(')

*"#

60 mL In

put

45 mL In

put

30 mL In

put

血液採取

分離・濃縮

抽出

MAGELLANシステムは、独自の最先端技術を応用し、カスタマイズされた多血小板血漿、他成分を迅速かつシンプルなボタン操作で採取する遠心分離システムです。

完全自動処理システム 全血液採取後の送液・多血小板血漿の遠心分離・濃縮・抽出・採取を全自動で実施します。簡単なセットアップ、シンプルなボタン操作により操作時間を大幅に短縮することができます。

クローズドシステム 無菌閉鎖回路使用により、感染リスクを最大限に低減しています。完全自動操作のクローズドシステムであることから、オペレータによる操作ミスの発生リスクがありません。

オプティカルセンサ 内蔵された光学センサにより自動的に

選択可能な抽出量・濃縮度 目的に合わせた血小板血漿の抽出量・濃縮度を選択することができます。また、乏血小板血漿(PPP) の分離採取等の操作オプションを追加選択 することも可能です。

デュアルスピンテクニック 全血液採取後の送液・多血小板血

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

多血小板血漿抽出量・濃縮度

多血小板血漿抽出量(mL)

多血小板血漿濃縮度(倍数)の上昇

全血液量(mL) 60 45 30

抽出量・濃縮度の例 60mLの全血液より3mLのPRPを抽出した場合の血小板濃縮度

Reference : AMSI Source: TS-0078-182.

Reference : AMSI Source: TS-0078-182.

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

14

12

10

8

6

4

2

0

Opt

ical

Sen

sors

Every

patient h

as a unique biology w

ith in

herent v

ariabilit

y, so

you need a so

lution

that is

customize

d for e

ach patient. G

o beyond th

e standard

of care

and deliver

a personaliz

ed biologic with

the M

agella

n Auto

logous C

oncentra

tion Sys

tem.

CUSTOM

IZED A

UTOLO

GOUS THERAPY

The fully

-automate

d Mage

llan sy

stem use

s pro

prieta

ry B

ioAdaptive

technology a

nd customiza

ble conce

ntratio

n facto

rs to

yield

a tailo

red

autologo

us solutio

n for e

ach patient.

DELIVER

PERSONALIZ

ED

MEDIC

INE

CONCENTRATE A

T THE P

USH OF A

BUTTO

N

SUPERIOR TECHNO

LOGY. S

UPERIOR P

ERFORM

ANCE.

Flexible & C

ost-Effe

ctive

Proce

sses u

p to th

ree

cycles p

er patie

nt usin

g a

single ki

t, with

flexibilit

y to

proce

ss bone m

arrow and

whole blood

Closed Syste

m

Minim

al bre

aks in

steril

e

barrier p

romote

safe

ty

FDA Cleare

d for

Orth

opedic Applic

ations

Proce

ssed m

arrow and

blood can be mixe

d with

allogra

ft or a

utogra

ft

Selectable O

utput

Allows u

sers

to defin

e desired th

erapeutic

volumes (

3–10 mL per c

ycle)

BioAdaptive Pro

cess

ing™

Smart t

echnology

adjusts

proce

ssing b

ased on pati

ent

biology to

optimize

resu

lts

Fully A

utomate

d

Simple one-b

utton st

art

for e

ase of u

se

Automatio

n

Ensure

s Qualit

y

Fully-auto

mated, c

losed

syste

m conce

ntrate

s

more co

nsiste

ntly th

an

manual sys

tems

Optic

al Senso

rs

Identif

y the ce

llular f

ractio

n to elim

inate erro

r and

optimize

resu

lts

Concentrate

s up

to 14x B

aselin

e1,2

Provid

es high

conce

ntratio

ns

of plat

elets, gr

owth fa

ctors

and pro

genito

r cells

Customiza

ble

Concentratio

n

Users

determ

ine potentia

l

conce

ntratio

n facto

r by

select

ing input a

nd desired

output v

olumes

BioAdaptive Pro

cess

ing

Work

s with

optical s

ensors

to ta

ilor p

roce

ssing

paramete

rs base

d on each pat

ient’s hemat

ocrit

CUSTOM

IZE P

OTENTIAL C

ONCENTRATIO

N FACTORS

HIGH IN

PUT VO

LUMES + LOW

OUTPUT V

OLUM

ES = HIG

HEST CO

NCENTRATION1

Users

can proce

ss 3

0–60 m

L per cyc

le (up to

180 m

L per patie

nt) and

select f

inal outp

ut volume betw

een 3–10

mL per c

ycle (u

p to 3

0 mL per

patient)

to custo

mize fin

al conce

ntratio

n.

Aspira

te

Conce

ntra

te

Deliv

er

Inpu

t Bon

e M

arro

w A

spira

te

(BM

A) o

r Blo

odRe

d Blo

od C

ells

(RBC

)

Sepa

rate

d

RBCs E

xtra

cted

Buffy

Coa

t Is

Con

cent

rate

d

Outp

ut = 10 m

L

Outp

ut = 6 m

L

Outp

ut = 3 m

L

Concentration Over Baseline

Mage

llan employs

cutting-e

dge te

chnology to pro

duce a custo

mized biologic

quickly and easil

y.

Nuc

leat

ed C

ells,

Plat

elet

s & G

row

th

Fact

ors R

eady

for

Imm

edia

te U

se

!"#

$%&'(%(')

*"#

60 mL In

put

45 mL In

put

30 mL In

put

14

12

10

8

6

4

2

0

Opt

ical

Sen

sors

Every

patient h

as a unique biology w

ith in

herent v

ariabilit

y, so

you need a so

lution

that is

customize

d for e

ach patient. G

o beyond th

e standard

of care

and deliver

a personaliz

ed biologic with

the M

agella

n Auto

logous C

oncentra

tion Sys

tem.

CUSTOM

IZED A

UTOLO

GOUS THERAPY

The fully

-automate

d Mage

llan sy

stem use

s pro

prieta

ry B

ioAdaptive

technology a

nd customiza

ble conce

ntratio

n facto

rs to

yield

a tailo

red

autologo

us solutio

n for e

ach patient.

DELIVER

PERSONALIZ

ED

MEDIC

INE

CONCENTRATE A

T THE P

USH OF A

BUTTO

N

SUPERIOR TECHNO

LOGY. S

UPERIOR P

ERFORM

ANCE.

Flexible & C

ost-Effe

ctive

Proce

sses u

p to th

ree

cycles p

er patie

nt usin

g a

single ki

t, with

flexibilit

y to

proce

ss bone m

arrow and

whole blood

Closed Syste

m

Minim

al bre

aks in

steril

e

barrier p

romote

safe

ty

FDA Cleare

d for

Orth

opedic Applic

ations

Proce

ssed m

arrow and

blood can be mixe

d with

allogra

ft or a

utogra

ft

Selectable O

utput

Allows u

sers

to defin

e desired th

erapeutic

volumes (

3–10 mL per c

ycle)

BioAdaptive Pro

cess

ing™

Smart t

echnology

adjusts

proce

ssing b

ased on pati

ent

biology to

optimize

resu

lts

Fully A

utomate

d

Simple one-b

utton st

art

for e

ase of u

se

Automatio

n

Ensure

s Qualit

y

Fully-auto

mated, c

losed

syste

m conce

ntrate

s

more co

nsiste

ntly th

an

manual sys

tems

Optic

al Senso

rs

Identif

y the ce

llular f

ractio

n to elim

inate erro

r and

optimize

resu

lts

Concentrate

s up

to 14x B

aselin

e1,2

Provid

es high

conce

ntratio

ns

of plat

elets, gr

owth fa

ctors

and pro

genito

r cells

Customiza

ble

Concentratio

n

Users

determ

ine potentia

l

conce

ntratio

n facto

r by

select

ing input a

nd desired

output v

olumes

BioAdaptive Pro

cess

ing

Work

s with

optical s

ensors

to ta

ilor p

roce

ssing

paramete

rs base

d on each pat

ient’s hemat

ocrit

CUSTOM

IZE P

OTENTIAL C

ONCENTRATIO

N FACTORS

HIGH IN

PUT VO

LUMES + LOW

OUTPUT V

OLUM

ES = HIG

HEST CO

NCENTRATION1

Users

can proce

ss 3

0–60 m

L per cyc

le (up to

180 m

L per patie

nt) and

select f

inal outp

ut volume betw

een 3–10

mL per c

ycle (u

p to 3

0 mL per

patient)

to custo

mize fin

al conce

ntratio

n.

Aspira

te

Conce

ntra

te

Deliv

er

Inpu

t Bon

e M

arro

w A

spira

te

(BM

A) o

r Blo

odRe

d Blo

od C

ells

(RBC

)

Sepa

rate

d

RBCs E

xtra

cted

Buffy

Coa

t Is

Con

cent

rate

d

Outp

ut = 10 m

L

Outp

ut = 6 m

L

Outp

ut = 3 m

L

Concentration Over Baseline

Mage

llan employs

cutting-e

dge te

chnology to pro

duce a custo

mized biologic

quickly and easil

y.

Nuc

leat

ed C

ells,

Plat

elet

s & G

row

th

Fact

ors R

eady

for

Imm

edia

te U

se

!"#

$%&'(%(')

*"#

60 mL In

put

45 mL In

put

30 mL In

put

血液採取

分離・濃縮

抽出

MAGELLANシステムは、独自の最先端技術を応用し、カスタマイズされた多血小板血漿-PRP (Platelet Rich Plasma)を迅速かつ簡単なボタン操作で採取する遠心分離システムです。

完全自動処理システム 抗凝固血液の送血・遠心分離・濃縮・抽出・回収を全自動で行います。簡単なセットアップ、シンプルなボタン操作により処理時間を大幅に短縮することができます。

クローズドシステム 無菌閉鎖回路使用により、感染リスクを最大限に低減しています。完全自動操作のクローズドシステムであることから、オペレータによる操作ミスの発生リスクがありません。

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

選択可能な抽出量・濃縮率 目的に合わせたPRPの抽出量・濃縮率を選択することができます。また、乏血小板血漿(PPP)の分離採取等の操作オプションを追加選択できます。

MAGELLAN15

10

5

0

11 1210

6

10

4

14

Growth Factors Post-Processing (60 mL -> 6 mL)

Con

cent

ratio

n F

acto

r

PDGF-AB PDGF-AA PDGF-BB VEGF FGF- EGFTGF- 1

97% cell viability4

Processing yields viable cells

Confirmed by characterization of CD markers 73+, 105+, 34+ or 133+ via flow cytometry

5–6x MSC & HSC concentration9

AMPLIFY ESSENTIAL GROWTH FACTORS UP TO 14 X BASELINE2

PROVEN TO CONCENTRATE VIABLE PROGENITOR CELLS

Data featuring Magellan MAR0Max™ demonstrates increased concentrations of MSC & HSC and IL-1Ra when compared to BMA and whole blood4,5.

• MSCs can differentiate into osteoblasts and chondrocytes6

• HSCs support blood vessel formation7

• IL-1Ra is reported to neutralize pain triggers5,8

MAGELLAN CONCENTRATES REGENERATIVE POTENTIAL

1400

1200

1000

800

600

400

200

0

6-FOLD

5-FOLD

2500

2000

1500

1000

500

0

5-FOLD6-FOLD

Cel

l Cou

nt (1

000

per m

L)

CD105+ CD73+

MSC CD MARKERS

1400

1200

1000

800

600

400

200

0

6-FOLD

5-FOLD

2500

2000

1500

1000

500

0

5-FOLD6-FOLD

Cel

l Cou

nt (1

000

per m

L)

CD133+ CD34+

HSC CD MARKERS

CELL CHARACTERIZATION OF MAR0MAX9

PDGFPlatelet-Derived Growth Factor

TGF-Transforming Growth Factor—Beta

VEGFVascular Endothelial Growth Factor

FGF- Fibroblast Growth Factor—Beta

EGFEpithelial Growth Factor

BioAdaptive processing yields superior performance94%

reduction in Red Blood Cells (RBC)9, 10

Platelets release various growth factors that influence cellular processes, including proliferation and differentiation, angiogenesis, and tissue repair2,3.

Baseline Concentrate

60mLの抗凝固血液より抽出した6mLのPRPに含まれる成長因子

成長因子 濃縮係数 PRP含まれる成長因子

血小板は、増殖や分化、血管新生、組織修復など、細胞プロセスに影響を与えるさまざまな成長因子を放出します。[1][2]

遠心分離が可能な抗凝固血液量 1サイクルの遠心分離で、30~60mLの抗凝固血液を処理できます。

抽出量の選択 3~10mLの範囲内1mL単位で抽出量を調整できます。

可能な最大抗凝固血量 1つの分離チャンバーで、3サイクル までの分離が可能です。(同一患者) 最大180mLの抗凝固血液の分離・濃縮が可能です。 PRP抽出量(mL)

遠心分離後の濃縮率

Reference : AMSI Source: TS-0078-182.

抽出量・濃縮率の例 60mLの抗凝固血液より3mLのPRPを抽出した場合の濃縮率

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

PRP抽出・回収量

抗凝固血液量

TGF-β トランスフォーミング成長因子

PDGF 血小板由来成長因子

FGF-β 線維芽細胞成長因子

VEGF 血管内皮成長因子

EGF 上皮成長因子

血液をチャンバー内へ送血

第1スピン 赤血球の分離 赤血球の排出

PRP・他成分の採取 [即使用可能な状態]

第2スピン 血小板・白血球層の分離濃縮

オプティカルセンサー

[2] Castillo T, et al. Comparison of growth factor and platelet concentration from commercial platelet-rich plasma separation systems. The American Journal of Sports Medicine. 2011. 39(2):266-271.

[1] Patel A, et al. Evaluation of autologous platelet-rich plasma for cardiac surgery: outcome analysis of 2000 patients. J Cardiothorac Surg. 2016. 11(1):62. doi: 10.1186/s13019-016-0452-9.

オプティカルセンサー 内蔵された光学センサーにより自動的に分離チャンバー(閉鎖回路内)のインターフェイス(細胞層の境界)が検知され、遠心分 離を自動的に最適化します。それぞれの分離処理パラメータを調整し、常に一定の濃度でPRPを抽出します。

Page 2: CONCENTRATE AT THE PUSH OF A BUTTON 45 6 し ......MAGELLANシステムは、独自の最先端技術を応用 し、カスタマイズされた多血小板血漿、他成分を迅

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

!"#$%&'()*+',)-.PSS_fcv.fm 3/4/08 03:04 pm

5.5 x 7.75 inches (139.7 mm x 196.85 mm)

M932609A001 Rev. 2A

!"#$%%"&'

"()*+*,*(-./+0)1+1).213040)*4.25-)16.789+(:;8,"--*9;0)1:.<;-3*-0=+1-

>3140)*4?-.!08(0+

M932798A001 Rev. 1.0

AMS95023LBL_REV 1_FC.fm 3/9/09 11:48 am 4.0 x 6.5 inches (101.6 mm x 165.1 mm)

AMS Confidential

!"#$%%"&Æ'()*+,-,./01*(123+,.40-

Instructions for Use

AMS95068LBL Rev. 2

BUILT TO CONCENTRATEMagellan® is an autologous concentration system that delivers concentrated platelets and cells at the point of care.

MAGELLANシステムの基本操作:PRP抽出・回収

ステップ③ 分離チャンバー内で遠心により成分分離層が形成された後、自動的に赤血球成分が60mLシリンジに回収されます。 赤血球成分の回収が完了すると、ステップ②で設定した抽出量のPRPが10mLシリンジに自動的に回収されます。

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

ステップ② コントロールパネルを操作し、PRP抽出量を設定します。スタートボタンを押し、分離サイクルを開始します。60mLシリンジに採取した抗凝固血液が自動的に分離チャンバーへ送血され、分離・濃縮を開始します。

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

総販売業者 株式会社トライテック 〒140-0013 東京都品川区南大井1-20-17 マニフィック南大井ビル3階 Tel. 03-5767-9831 Fax. 03-5767-9839

品  名:MAGELLANシステム 製品コード:CMS AMS100 JANコード:4580081580227 寸   法 :幅47cm・高さ32cm・奥行き44cm 重   量:11kg 定 格 電 流:100-240V 定格周波数:50/60Hz 電 源 入 力 : 1.3A 製造販売承認番号:23100BZX00024000

製造販売業者:クリスメディカルソリューションズ株式会社 〒158-0083 東京都世田谷区奥沢3丁目35-11 第一種医療機器製造販売業許可番号:13B1X10259

品  名:MAGELLANディスポーザブルキット 製品コード:CMS AMS305 JANコード:4580081580241 構成品(全て滅菌品) 分離チャンバー 60mLシリンジ 30mLシリンジ シリンジキャップ 抗凝固剤(ACD-A)50mL

本キットに含まれる60mL、10mシリンジは各1本となります。2回目、3回目の分離を実施する際には新たなシリンジが必要となります。

本システムおよびキットにに関する詳細については、下記までお問い合わせください。

ステップ① MAGELLANシステムの電源を入れます。MAGELLANシステムのカバーを開け、キットより取り出した閉鎖回路(分離チャンバー)をMAGELLANシステムに取り付けます。付属の専用60mLシリンジでキットに含まれるACD-Aを規定量注入し、施設のプロトコルに従い患者より血液を採取します。60mLシリンジ、及びPRP回収用の空の10mLをMAGELLANシステムに清潔操作にて取り付け、各シリンジのチューブを閉鎖回路のチューブと接続します。全てのカバーを閉じます。

BUILT TO CONCENTRATEMagellan® is an autologous concentration system that delivers concentrated platelets and cells at the point of care.

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

!"#$%&'()*+',)-.PSS_fcv.fm 3/4/08 03:04 pm

5.5 x 7.75 inches (139.7 mm x 196.85 mm)

M932609A001 Rev. 2A

!"#$%%"&'

"()*+*,*(-./+0)1+1).213040)*4.25-)16.789+(:;8,"--*9;0)1:.<;-3*-0=+1-

>3140)*4?-.!08(0+

M932798A001 Rev. 1.0

AMS95023LBL_REV 1_FC.fm 3/9/09 11:48 am 4.0 x 6.5 inches (101.6 mm x 165.1 mm)

AMS Confidential

!"#$%%"&Æ'()*+,-,./01*(123+,.40-

Instructions for Use

AMS95068LBL Rev. 2

MAGELLANシステムの基本操作:PRP抽出・回収

ステップ③ 分離チャンバー内で遠心により成分分離層が形成された後、自動的に赤血球成分が60mLシリンジに回収されます。 赤血球成分の回収が完了すると、ステップ②で設定した抽出量のPRPが10mLシリンジに自動的に回収されます。

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

ステップ② コントロールパネルを操作し、PRP抽出量を設定します。スタートボタンを押し、分離サイクルを開始します。60mLシリンジに採取した 抗凝固血液が自動的に分離チャンバーへ送血され、分離・濃縮を開始します。

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

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60 mL Input

45 mL Input

30 mL Input

14

12

10

8

6

4

2

0

Optical Sensors

Every patient has a unique biology with inherent variability, so you need a solution that is customized for each patient. Go beyond the standard of care and deliver a personalized biologic with the Magellan Autologous Concentration System.

CUSTOMIZED AUTOLOGOUS THERAPY The fully-automated Magellan system uses proprietary BioAdaptive technology and customizable concentration factors to yield a tailored autologous solution for each patient.

DELIVER PERSONALIZED MEDICINE

CONCENTRATE AT THE PUSH OF A BUTTON

SUPERIOR TECHNOLOGY. SUPERIOR PERFORMANCE.

Flexible & Cost-Effective

Processes up to three cycles per patient using a single kit, with flexibility to process bone marrow and whole blood

Closed System Minimal breaks in sterile barrier promote safety

FDA Cleared for Orthopedic Applications

Processed marrow and blood can be mixed with allograft or autograft

Selectable Output Allows users to define desired therapeutic volumes (3–10 mL per cycle)

BioAdaptive Processing™

Smart technology adjusts processing based on patient biology to optimize results

Fully AutomatedSimple one-button start for ease of use

Automation Ensures Quality

Fully-automated, closed system concentrates more consistently than manual systems

Optical Sensors Identify the cellular fraction to eliminate error and optimize results

Concentrates up to 14x Baseline1,2

Provides high concentrations of platelets, growth factors and progenitor cells

Customizable Concentration

Users determine potential concentration factor by selecting input and desired output volumes

BioAdaptive Processing Works with optical sensors to tailor processing parameters based on each patient’s hematocrit

CUSTOMIZE POTENTIAL CONCENTRATION FACTORS

HIGH INPUT VOLUMES + LOW OUTPUT VOLUMES = HIGHEST CONCENTRATION1

Users can process 30–60 mL per cycle (up to 180 mL per patient) and select final output volume between 3–10 mL per cycle (up to 30 mL per patient) to customize final concentration.

Aspirate

Concentrate

Deliver

Input Bone Marrow Aspirate (BMA) or Blood

Red Blood Cells (RBC) Separated

RBCs Extracted

Buffy Coat Is Concentrated

Output = 10 mL Output = 6 mL Output = 3 mL

Con

cent

ratio

n O

ver B

asel

ine

Magellan employs cutting-edge technology to produce a customized biologic quickly and easily.

Nucleated Cells, Platelets & Growth Factors Ready for Immediate Use

!"#

$%&'(%(')

*"#

60 mL Input

45 mL Input

30 mL Input

総販売業者 株式会社トライテック 〒140-0013 東京都品川区南大井1-20-17 マニフィック南大井ビル3階 Tel. 03-5767-9831 Fax. 03-5767-9839

製造販売業者:クリスメディカルソリューションズ株式会社 〒158-0083 東京都世田谷区奥沢3丁目35-11 第一種医療機器製造販売業許可番号:13B1X10259

品  名:MAGELLANディスポーザブルキット 製品コード:CMS AMS305 JANコード:4580081580241 構成品(全て滅菌品) 分離チャンバー 60mLシリンジ 10mLシリンジ シリンジキャップ 抗凝固剤(ACD-A)50mL

本キットに含まれる60mL、10mLシリンジは各1本となります。2回目、3回目の分離を実施する際には新たなシリンジが必要となります。

本システムおよびキットに関する詳細については、下記までお問い合わせください。

ステップ① MAGELLANシステムの電源を入れます。MAGELLANシステムのカバーを開け、キットより取り出した分離チャンバー(閉鎖回路)をMAGELLANシステムに取り付けます。付属の専用60mLシリンジでキットに含まれるACD-Aを規定量注入し、施設のプロトコルに従い患者より血液を採取します。60mLシリンジ、及びPRP回収用の空の10mLシリンジをMAGELLANシステムに清潔操作にて取り付け、各シリンジのチューブを分離チャンバーのチューブと接続します。全てのカバーを閉じます。

品  名:MAGELLANシステム 製品コード:CMS AMS100 JANコード:4580081580227 寸   法 :幅47cm・高さ32cm・奥行き44cm 重   量:11kg 定 格 電 流:100-240V 定格周波数:50/60Hz 電 源 入 力 : 1.3A 製造販売承認番号:23100BZX00024000

MAGELLANシステム