upsylon y-mesh and vaginal positioning device product ......91006020-01 rev. b boston scientific...

Product Review for the Purchasing Committee

Upsylon™ Y-Mesh and

Colpassist™ Vaginal Positioning Device

Contents

Product Overview

Upsylon™ Y-Mesh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Colpassist™ Vaginal Positioning Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

510k Clearance and Exempt Letters

Upsylon™ Y-Mesh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Colpassist™ Vaginal Positioning Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Directions for Use

Upsylon™ Y-Mesh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Colpassist™ Vaginal Positioning Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Reimbursement Guide

Upsylon™ Y-Mesh and Colpassist™ Vaginal Positioning Device . . . . . . . . . . . . . 15

Ordering information

Upsylon™ Y-Mesh and Colpassist™ Vaginal Positioning Device . . . . . . . . . . . . . 17

2Product Review for the Purchasing Committee

Product Overview

Upsylon™ Y-Mesh


The Colpassist Vaginal Positioning Device is the first device specifically designed for vaginal positioning in gynecologic procedures and as a suturing platform for vaginal wall fixation during sacrocolpopexy.

• Two size end options each offering a flat suturing surface

• Facilitates multi-direction vaginal manipulation during dissection and mesh placement

Image owned by Boston Scientific

Figure 2: Picture of posterior dissection performed with Colpassist Vaginal Positioning Device providing positioning.

Upsylon Y-Mesh is intentionally designed to deliver both low density and high durability, driving procedural ease through exceptional handling and dynamic, tear-resistant design.

• Mesh characteristics designed to match physiologic characteristics of the vaginal wall

• Handling characteristics designed to ease mesh positioning, placement and fixation

• Pore size optimized to help promote mesh integration;1,2 and open pore structure facilitates passage of needle and ease of suturing

• Unique finishing process provides smooth, thinner mesh and optimal bending stiffness, allowing mesh to lay flat and resist tenting during fixation1

• Blue color and centering line provide enhanced visualization and orientation during placement

Image provided courtesy of Dr. Salamon

Figure 1: Picture of Upsylon Y-Mesh shows contrast of blue mesh and surrounding anatomy.



Upsylon™ Y-Mesh


February 2, 2013

Dear Valued Customer,

Thank you for your inquiry regarding the ColpassistTM Vaginal Positioning Device. This information is provided in response to your direct request for regulatory information and may not be used for any other purpose without the expressed written permission of Boston Scientific Corporation.

The ColpassistTM Vaginal Positioning Device, order number M0068318210 complies with US Federal Regulation 21 CFR 884.4520, Instrument, Manual, General Obstetric-Gynecologic, and is 510(k) exempt. FDA does not require a 510(k) premarket notification for this device type.

Please feel free to your local sales representative or Boston Scientific directly should you have any additional questions or require additional information.

Sincerely,

Boston Scientific Regulatory Affairs




Directions for Use

Upsylon™ Y-Mesh

91006020-01 Rev. B

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Black (K) ∆E ≤5.0

Directions for Use 2

Upsylon™

Traditional Y Mesh

2016-03

Instrucciones de uso 6

Mode d’emploi 9

Gebrauchsanweisung 12

Istruzioni per l’uso 15

Gebruiksaanwijzing 18

Instruções de Utilização 21

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Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0

ONLYCaution: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in performing mesh procedures for surgical repair of pelvic organ prolapse.

warnInGContents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

DEVICE DESCrIPTIOnUpsylon Mesh is a preformed Y shaped lightweight polypropylene mesh consisting of two vaginal mesh arms and one sacral mesh arm. The Upsylon Mesh is blue in color with a non-colored centering line.

InTEnDED USEUpsylon Mesh is intended for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

COnTraInDICaTIOnSUpsylon Mesh is contraindicated for use in any patient in whom soft tissue implants are contraindicated. These patients include those with:• Pathologyofthesofttissueintowhichthesyntheticmeshis

to be placed.• Patientswithfuturegrowthpotential,pregnantpatients,or

patients that are considering future pregnancies.• Ananatomythatcompromisesdeviceimplantorpathology

that limits blood supply or compromises healing.• Autoimmuneconnectivetissuedisease.• Pre-existinglocalorsystemicinfection.• Bloodcoagulationdisorder.

warnInGS• Theeffectivenessofthisproducthasnotbeenevaluatedin

a prospective randomized clinical trial.• Theimplantprocedurecarriesriskofinfectionand

bleeding, inherent with open, laparoscopic, or robotic procedures.

• Intheeventofpostprocedureinfection,theentiremeshmay have to be removed.

• Meshisconsideredapermanentimplant.Removalofmeshor correction of mesh-related complications may involve multiple surgeries.

Upsylon™

Traditional Y Mesh

1 . English DFU shown for illustrative purposes only. Please refer to current version of the DFU.


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• Infection• Inflammation(acuteorchronic)• Injurytoureter• Meshandortissuecontracture• Necrosis• Nerveinjury• Organperforation• Pain,ongoingpain• Post-operativebowelobstruction• Prolapse/Recurrentprolapse• Urinaryandorfecalincontinence• Urinaryretention• VaginalshorteningorstenosisThe occurrence of these events may require surgical intervention. In some instances the response to these event may persist as a permanent condition after the intervention.

HOw SUPPLIEDUpsylon™ Synthetic Mesh is supplied sterile in single use, single peel packages. Do not use if package is opened or damaged. Do not use if labeling is incomplete or illegible.

OPEraTIOnS InSTrUCTIOnS1. Prepareanatomyusingalaparotomy,laparoscopic

or robotic approach. Surgical preparation for mesh attachment should be performed on the vaginal walls and the anterior longitudinal ligament overlying the sacral promontory.

2. Introduce the Y mesh into the pelvic cavity, ensuring that the anterior and posterior arms are oriented to the corresponding anatomy. A non-colored centering line appears on the posterior arm and sacral arm of the Y mesh.

note: The order of vaginal mesh attachment, ie. anterior before posterior/posterior before anterior, is at the discretion of the implanting physician, (but the vaginal attachments should be placed before securing the mesh to the sacrum).

3. Using standard fixation techniques, sutures may be used to fix the mesh to the vaginal walls per physician preference. Ensure that fixation is placed with at least two rows of empty pores (4 mm) from any mesh edge. Excess mesh beyond 4 mm from any mesh edge may be trimmed.

4. Ensuring appropriate tension, attach the sacral arm of the Y mesh to the anterior longitudinal ligament of the sacral promontory. Excess mesh beyond 4 mm from any mesh edge may be trimmed.

5. Reperitonealization over the mesh is recommended.

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• Completeremovalofmeshmaynotbepossibleandadditional surgeries may not always fully correct the complications.

• Perforationsorlacerationsofvessels,nerves,bladder,ureters, urethra or bowel may occur during placement and may require surgical repair.

• Aswithallforeignbodies,themeshmaypotentiateanexisting infection reaction or sepsis.

PrECaUTIOnS• Physiciansshouldbetrainedintheplacementofsurgical

mesh devices for treatment of pelvic floor disorders and in management of complications resulting from these procedures.

• Standardsurgicalpracticesshouldbefollowedforpelvic floor procedures as well as for the management of contaminated or infected wounds.

• Anassessmentofeachpatientshouldbemadetodetermine their suitability for a synthetic mesh procedure, considering the patient’s prior abdominal or pelvic surgeries.

• Aswithallsurgicalprocedures,certainriskfactorsareknown to impact patient outcomes in the pelvic floor which include, but are not limited to, impaired vascularity (e.g. diabetes, smoking status, estrogen status, pelvic floor radiation exposure, etc.), age, pelvic floor myalgia, impaired wound healing (e.g. diabetes, steroid usage, etc.), or active infection in or near the surgical site. The above pathophysiologic conditions must be considered when determining whether the patient is an appropriate candidate for mesh implantation, either by transvaginal or transabdominal route.

• Theuseofpolypropylenemeshinurogynecologicprocedures such as the treatment of pelvic organ prolapse, regardless of the route of delivery (transvaginal or transabdominal), has been associated with cases of erosion. Erosion has been reported in bladder, vagina, urethra, ureter, and bowel. Treatment of the erosion may require surgical removal.

• Aseptictechniquemustbeadheredtothroughoutprocedure.

• Donotuseproductifpastthedateofexpiration.• Itisrecommendedthatpatientsbecounseledtorefrain

from heavy lifting, exercise, and intercourse for a minimum of six (6) weeks after the procedure. Follow physician’s recommendations.

• Itisrecommendedthatpatientsbecounseledtocontacttheir physician in the case of post-operative bleeding, dysuria or other problems.

• Thereshouldbeanappropriatemarginofmeshextendingbeyond the suture line. Inadequate suturing of the mesh material to the pelvic tissue may lead to failure of the repair and recurrence of the prolapse.

• Futurepregnancymaynegatetheeffectofsurgicalrepair.

aDVErSE EVEnTS• Adhesionformation• Allergicreaction(hypersensitivity)• Constipation• Dehiscence• Dyspareunia• Erosionorextrusion• Fistulaformation• Granulationtissueformation• Hemorrhage


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warranTyBoston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose.Handling,storage,cleaningandsterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond BSC’s control directly affect the instrument and the results obtained from its use. BSC’s obligation under this warranty is limited to the repair or replacement of this instrument and BSC shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this instrument. BSC neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument. BSC assumes no liability with respect to instruments reused, reprocessed or resterilized and makes no warranties, express or implied, including but not limited to merchantability or fitness for a particular purpose, with respect to such instruments.

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Catalog NumberNúmero de catálogoNuméro de catalogueBestell-Nr.Numero di catalogoCatalogusnummerReferência

rEF

Consult instructions for use.Consultar las instrucciones de uso.Consulter le mode d’emploi.Gebrauchsanweisung beachten.Consultare le istruzioni per l'uso.Raadpleeg instructies voor gebruik.Consulte as Instruções de Utilização

EU Authorized RepresentativeRepresentante autorizado en la UEReprésentant agréé UEAutorisierter Vertreter in der EURappresentante autorizzato per l'UEErkend vertegenwoordiger in EURepresentante Autorizado na U.E.

EC REP

Legal ManufacturerFabricante legalFabricant légalBerechtigter HerstellerFabbricante legaleWettelijke fabrikantFabricante Legal

LotLoteLotChargeLottoPartijLote

LOT

Recyclable PackageEnvase reciclableEmballage recyclableWiederverwertbare VerpackungConfezione riciclabileRecyclebare verpakkingEmbalagem Reciclável

Australian Sponsor AddressDirección del patrocinador australianoAdresse du promoteur australienAdresse des australischen SponsorsIndirizzo sponsor australianoAdres Australische sponsorEndereço do Patrocinador Australiano

AUS

Brazil Local ContactContacto local en BrasilContact local au BrésilLokaler Kontakt BrasilienContatto locale per il BrasileContactpersoon BraziliëContacto local no Brasil

BRA

Argentina Local ContactContacto local en ArgentinaContact local en ArgentineLokaler Kontakt ArgentinienContatto locale per l'ArgentinaContactpersoon ArgentiniëContacto local na Argentina

ARG

ContentsContenidoContenuInhaltContenutoInhoudConteúdo

Use ByFecha de caducidadDate limite d’utilisationVerwendbar bisUsare entroUiterste gebruiksdatumValidade


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© 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

LegalManufacturer

Manufactured for:Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752USAUSA Customer Service 888-272-1001

BrazilLocal ContactBRA

Para informações de contato da Boston Scientific do Brasil Ltda, por favor, acesse o link www.bostonscientific.com/bra

EU AuthorizedRepresentative

Boston Scientific LimitedBallybrit Business ParkGalwayIRELAND

EC REP

recyclablePackage

0344

AustralianSponsor Address

Boston Scientific (Australia) Pty LtdPO Box 332BOTANYNSW 1455AustraliaFree Phone 1800 676 133Free Fax 1800 836 666

AUS

Do not use if packageis damaged.

ArgentinaLocal ContactARG

Para obtener información de contacto de Boston Scientific Argentina SA, por favor, acceda al link www.bostonscientific.com/arg

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For single use only. Do not reuse.Para un solo uso. No reutilizar.À usage unique. Ne pas réutiliser.Für den einmaligen Gebrauch. Nicht wieder verwenden.Esclusivamente monouso. Non riutilizzare.Uitsluitend bestemd voor eenmalig gebruik. Niet opnieuw gebruiken.Apenas para uma única utilização. Não reutilize.

Do Not ResterilizeNo reesterilizarNe pas restériliserNicht erneut sterilisierenNon risterilizzareNiet opnieuw steriliserenNão reesterilize

STErILIZE2

Do not use if package is damaged.No usar si el envase está dañado.Ne pas utiliser si l’emballage est endommagé.Bei beschädigter Verpackung nicht verwenden.Non usare il prodotto se la confezione è danneggiata.Niet gebruiken als de verpakking is beschadigd.Não utilize se a embalagem estiver danificada.

Sterilized using ethylene oxide.Esterilizado por óxido de etileno.Stérilisé à l’oxyde d’éthylène.Mit Ethylenoxid sterilisiert.Sterilizzato con ossido di etilene.Gesteriliseerd met ethyleenoxide.Esterilizado por óxido de etileno.

STERILE EO


Directions for Use


91006019-01 Rev. A

Instrucciones de uso 5

Mode d’emploi 8

Gebrauchsanweisung 11

Istruzioni per l’uso 14

Gebruiksaanwijzing 17

Instruções de Utilização 20

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Colpassist™Vaginal Positioning Device

Directions for Use 2

2015-03

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onLY

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

warnInGContents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

DevICe DesCrIptIonThe Colpassist Vaginal Positioning Device is a vaginal positioning device molded from blue acrylonitrile butadiene styrene (ABS) material with a curved shaft and two uniquely sized end options. Each sized end features a flat surface, which may be used to facilitate suturing. The surgeon will choose the appropriate sized end based on vaginal width.

IntenDeD Use / InDICatIons for UseThe Vaginal Positioning Device is intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. It may also be used as support/back-stop for potential vaginal attachment during sacrocolposuspension/sacrocolpopexy. The device can be used with tactile feedback and/or direct visualization.

ContraInDICatIonsNone known.

warnInGs

• Donotuseexcessiveforceduringtheinsertionandmovement of the device within the vagina.

preCaUtIons• Aseptictechniquemustbeadheredtothroughout

procedure.

Colpassist™Vaginal Positioning Device

1 . English DFU shown for illustrative purposes only. Please refer to current version of the DFU.


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aDverse events• TissueDamage• Perforation

How sUpplIeDThe Colpassist™ Vaginal Positioning Device is supplied sterile in single use, single peel packages. Do not use if package is opened or damaged.Do not use if labeling is incomplete or illegible.Handling and storageStore in a cool, dry, dark place.

operatIonal InstrUCtIonsExamine packaging and reject product if packaging is damaged or has been previously opened.Peel open pouch and aseptically deliver product to sterile field.Based on the patient’s anatomy, the surgeon should choose the appropriately sized Colpassist end.The Colpassist Vaginal Positioning Device can be used with lubricating gels to facilitate insertion and movement.

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warrantyBoston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this instrument. this warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and sterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond BSC’s control directly affect the instrument and the results obtained from its use. BSC’s obligation under this warranty is limited to the repair or replacement of this instrument and BSC shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this instrument. BSC neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument. BsC assumes no liability with respect to instruments reused, reprocessed or resterilized and makes no warranties, express or implied, including but not limited to merchantability or fitness for a particular purpose, with respect to such instruments.


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Do Not ResterilizeNo reesterilizarNe pas restériliserNicht erneut sterilisierenNon risterilizzareNiet opnieuw steriliserenNão reesterilize

stErILIZE2

Do not use if package is damaged.No usar si el envase está dañado.Ne pas utiliser si l’emballage est endommagé.Bei beschädigter Verpackung nicht verwenden.Non usare il prodotto se la confezione è danneggiata.Niet gebruiken als de verpakking is beschadigd.Não utilize se a embalagem estiver danificada.

For single use only. Do not reuse.Para un solo uso. No reutilizar.À usage unique. Ne pas réutiliser.Für den einmaligen Gebrauch. Nicht wieder verwenden.Esclusivamente monouso. Non riutilizzare.Uitsluitend bestemd voor eenmalig gebruik. Niet opnieuw gebruiken.Apenas para uma única utilização. Não reutilize.


STERILE EO

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Catalog NumberNúmero de catálogoNuméro de catalogueBestell-Nr.Numero di catalogoCatalogusnummerReferência

rEF

Consult instructions for use.Consultar las instrucciones de uso.Consulter le mode d’emploi.Gebrauchsanweisung beachten.Consultare le istruzioni per l'uso.Raadpleeg instructies voor gebruik.Consulte as Instruções de Utilização

ContentsContenidoContenuInhaltContenutoInhoudConteúdo

EU Authorized RepresentativeRepresentante autorizado en la UEReprésentant agréé UEAutorisierter Vertreter in der EURappresentante autorizzato per l'UEErkend vertegenwoordiger in EURepresentante Autorizado na U.E.

EC REP

Legal ManufacturerFabricante legalFabricant légalBerechtigter HerstellerFabbricante legaleWettelijke fabrikantFabricante Legal

LotLoteLotChargeLottoPartijLote

LOt

Recyclable PackageEnvase reciclableEmballage recyclableWiederverwertbare VerpackungConfezione riciclabileRecyclebare verpakkingEmbalagem Reciclável

Use ByFecha de caducidadDate limite d’utilisationVerwendbar bisUsare entroUiterste gebruiksdatumValidade

Australian Sponsor AddressDirección del patrocinador australianoAdresse du promoteur australienAdresse des australischen SponsorsIndirizzo sponsor australianoAdres Australische sponsorEndereço do Patrocinador Australiano

AUS

Argentina Local ContactContacto local en ArgentinaContact local en ArgentineLokaler Kontakt ArgentinienContatto locale per l'ArgentinaContactpersoon ArgentiniëContacto local na Argentina

ARG


STERILE EO

Brazil Local ContactContacto local en BrasilContact local au BrésilLokaler Kontakt BrasilienContatto locale per il BrasileContactpersoon BraziliëContacto local no Brasil

BRA

Product NumberNúmero del productoRéférenceProduktnummerCodice prodottoProductnummerNúmero do Produto

UPn


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LegalManufacturer

Manufactured for:Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752USAUSA Customer Service 888-272-1001

EU AuthorizedRepresentative

Boston Scientific LimitedBallybrit Business ParkGalwayIRELAND

EC REP

recyclablePackage

0344

AustralianSponsor Address

Boston Scientific (Australia) Pty LtdPO Box 332BOTANYNSW 1455AustraliaFree Phone 1800 676 133Free Fax 1800 836 666

AUS

Do not use if packageis damaged.

ArgentinaLocal ContactARG

Para obtener información de contacto de Boston Scientific Argentina SA, por favor, acceda al link www.bostonscientific.com/arg

BrazilLocal ContactBRA

Para informações de contato da Boston Scientific do Brasil Ltda, por favor, acesse o link www.bostonscientific.com/bra


Is this product reimbursable by insurance?The procedure for which it is used are reimbursable. Billing guides with respective coding and estimated Medicare reimbursement for relevant sacrocolpopexy procedures are available online at https://www.bostonscientific.com/en-US/reimbursement/women-s-health.html .

For additional coding and reimbursement information contact your local Territory Manager or the Women’s Health Reimbursement Help Desk at 508-683-4022

What is the Medicare Pass-Through Code (aka C-code or HCPCS)? C1763 (Connective Tissue, non-human (includes synthetic)).

C-Codes are tracking codes established by the Centers for Medicare & Medicaid Services (CMS) to assist Medicare in establishing future APC payment rates. C-Codes only apply to Medicare hospital outpatient claims. They do not trigger additional payment to the facility today. It is very important that hospitals report C-Codes as well as the associated device costs. This will help inform future outpatient hospital payment rates, including upward adjustments when appropriate.

Is this a patient-chargeable product?“Patient chargeable” is a colloquial term used by hospitals to convey that a device/supply is appropriately charged to the patient’s account (i.e. as a distinct line item on the patients claim) in the hospital/facility’s patient accounting or AR system. It does not mean that the patient is actually charged directly for the device/supply nor would an insured patient ever pay an additional amount “out of pocket” for the device/supply.

The fact that a hospital/facility chooses to designate certain devices/supplies (e.g. single-use devices) as “patient chargeable” will not in and of itself result in immediate increased reimbursement for the hospital/facility. It will allow CMS to better factor the true cost of the procedure into future Medicare reimbursement rate setting. It may also help in negotiations with private payers by more clearly demonstrating novel device costs that have been introduced to a procedure.

The designation of a given device/supply as “patient chargeable” is entirely up to the discretion and policy of the individual hospital/facility. Section 2202.8 of the Medicare Provider Reimbursement Manual dealing with Ancillary Services (e.g. operating room) does not specifically address which items are part of the basic (routine) charge and which are charged in addition to the basic charge (non-routine). Medicare is on record that it is up to the individual hospital to determine whether to and how to itemize the charge for a specific device/supply or alternatively, incorporate it into overhead (e.g. via the OR charge). However, Medicare does require that whatever method is chosen be applied consistently. They also require that charges billed on the CMS-1450 form (aka UB-04) be aggregated under the appropriate Revenue Code.

The appropriate Revenue Code is 272 – Medical/Surgical Supplies and Devices-Sterile Supply.

Reimbursement Guide

Upsylon™ Y-Mesh and Colpassist™ Vaginal Positioning Device


https://www.bostonscientific.com/en-US/reimbursement/women-s-health.html

https://www.bostonscientific.com/en-US/reimbursement/women-s-health.html

Relevant CPT and ICD-10 Codes:Payer policies will vary and should be verified prior to treatment for limitations on coding or site of service requirements. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options.

Procedure Name

APC Code

CPT® Code ICD-10-PCS Procedure Code

ICD-10-CM Diagnosis Code

Possible MS DRG Assignment

Level II Laparoscopy

5362

n/a

57425 –Laparoscopy, surgical, colpopexy (suspension of vaginal apex)

57280 – Colpopexy, abdominal approach (Inpatient only)

0USG4ZZ – Reposition Vagina, Percutaneous Endoscopic Approach

0USG0ZZ – Reposition Vagina, Open Approach

0UUG0JZ – Supplement Vagina with Synthetic Substitute, Open Approach

N81.2 – Incomplete uterovaginal prolapse

N81.3 – Complete uterovaginal prolapse

N81.4 – Uterovaginal prolapse, unspecified

N81.82 – Incompetence or weakening of pubocervical tissue

N81.83 – Incompetence or weakening of rectovaginal tissue

N81.85 – Cervical stump prolapse

N81.89 – Other female genital prolapse

N99.3 – Prolapse of vaginal vault after hysterectomy

662 – Minor bladder procedures with major complication or comorbidity (MCC)

663 – Minor bladder procedures with complication or comorbidity (CC)

664 – Minor bladder procedures without CC/MCC

748 – Female reproductive system reconstructive procedures

ICD-10 Note: It is the responsibility of the physician to code to the highest level of specificity. Selection of ICD-10-CM or ICD-10-PCS code(s) for a current condition, symptom, or complaint must first support the reason for the visit and accurately reflect the encounter. Any additional conditions, symptoms, or complaints that impact current care, or where a patient is receiving care for the condition may be reported (i.e. chronic or past condition, family history, etc.). Consult the current ICD-10-CM or ICD-10-PCS manual for the most accurate diagnosis codes and coding guidance.

This coding information may include codes for procedures for which Boston Scientific currently offers no cleared or approved products. In those instances, such codes have been included solely in the interest of providing users with comprehensive coding information and are not intended to promote the use of any Boston Scientific products for which they are not cleared or approved. The Health Care Provider (HCP) is solely responsible for selecting the site of service and treatment modalities appropriate for the patient based on medically appropriate needs of that patient and the independent medical judgement of the HCP.

Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules, and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider’s responsibility to determine medical necessity, the proper site for delivery of any services, and to submit appropriate codes, charges, and modifiers for services rendered. It is also always the provider’s responsibility to understand and comply with Medicare national coverage determinations (NCD), Medicare local coverage determinations (LCD), and any other coverage requirements established by relevant payers which can be updated frequently. Boston Scientific recommends that you consult with your payers, reimbursement specialists, and/or legal counsel regarding coding, coverage, and reimbursement matters. Information included herein is current as of November 2019 but is subject to change without notice. Rates for services are effective January 1, 2019.

Boston Scientific does not promote the use of its products outside their FDA-approved label.

Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding, or site of service requirements. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options.

CPT® Disclaimer Current Procedural Terminology (CPT) Copyright 2019 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions apply to government use. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.


Ordering information

Upsylon™ Y-Mesh and Colpassist™ Vaginal Positioning Device

Order Number Description Unit

M0068318200 Upsylon Y-Mesh Each

M0068318210 Colpassist Vaginal Positioning Device Each

M0068318220 Upsylon Y-Mesh and Colpassist Vaginal Positioning Device Kit Each


1 . Testing was performed by or on behalf of BSC. Data on file.

2 . Barone WR, Moalli PA, Abramowitch SD, et al. Textile properties of synthetic prolapse mesh in response to uniaxial loading. Am J Obstet Gynecol. 2016 Sep;215(3):326.e1-9.

For Upsylon Y-Mesh: Caution: U.S. Federal law restricts this device to sale by or on the order of a physician trained in performing mesh procedures for surgical repair of pelvic organ prolapse.

For Colpassist Vaginal Positioning Device: Accordingly for medical devices: Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Refer to package insert provided with this product for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and Instructions prior to using this product.

All trademarks are the property of their respective owners. All images are owned by Boston Scientific.

Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 www.bostonscientific.com


WH-147218-AC JAN 2020

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