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1 HEALAFLOW TECHNICAL SHEET
2 HEALAFLOW CHARACTERISTICS
3 HEALAFLOW GLAUCOMA FILTERING SURGERIES
4 HEALAFLOW RETROSPECTIVE STUDIES
5 HEALAFLOW UBM IMAGES
6 HEALAFLOW CONCLUSIONS
7 HEALAFLOW NOTES
8 HEALAFLOW DVD
CONTENT
HealaFlow is a slowly resorbable crosslinked viscoelastic gel indicated
for penetrating and non-penetrating glaucoma surgery. Injected under
the scleral flap and conjunctiva, it acts as a drainage implant and limits
the postoperative fibrosis thus improving the surgical success rate.
HealaFlow is made up of 22.5 mg/ml crosslinked sodium
hyaluronate (non animal origin).
Technical sheet
• HA concentration 22.5 mg/ml
• Molecular weight > 2.5 Mda
• Crosslinking agent BDDE (1.4-Butanediol diglycidyl ether)
• Origin of the polymer Non animal /biofermentation
• PH Physiological pH (7.0)
• Osmolarity Physiological Osmolarity (305 mOsm/kg)
• Endotoxin content 0.5 EU/ml
• Low protein rate < 50 ppm
• Sterilization Autoclave sterilization
HEALAFLOW TECHNICAL SHEET1
Nature Abhors a Vacuum 01
”Nature abhors a vacuum”Aristotle
1 | A spaces-filling product
• Long-lasting effect: stabilizes a patent scleral lake and
a durable filtering bleb beyond its slow resorption
• Prevents adhesions between flap and sclera & between
conjunctiva and episcleral tissue
2 | An anti-inflammatory effect
• HA inhibits inflammation and fibrosis (inhibits cytokins,
cell migration, phagocitose and lymphocyt transformation)
• The site of surgery remains quiet
3 | Non-animal origin
• Improved safety
• Less risk of allergy caused by animal proteins
• Non-toxic
• Highly purified
4 | Easy-to-use, an injectable implant
• Gel texture
• HealaFlow is presented in a 0.6 ml disposable
glass syringe 25 Gauge 7/8 canula
• Sterile - Colorless - Totally transparent
Indication
HealaFlow is indicated in all types of glaucoma surgeries
(penetrating, non-penetrating, shunts, stents, tubes).
HealaFlow can be injected:
• Into the scleral lake · Fig. 1
• Under the scleral flap · Fig.2
• Under the conjunctiva · Fig.3
Dosage and Administration
During glaucoma surgery, HealaFlow will be injected under the scleral flap and
between the sclera and the conjunctiva in order to provide a space-occupying
effect and to control the wound healing process. The surgeon should inject only
a small quantity of HealaFlow (0.05-0.1 ml) under the scleral flap and a larger
amount (0.2-0.4 ml) under the conjunctiva.
We recommend not to inject HealaFlow intracamerally to avoid pressure spike.
HEALAFLOW CHARACTERISTICS2
Nature Abhors a Vacuum02
Fig.2 Under the scleral flap
Fig.3 Under the conjunctiva
Fig. 1 Into the scleral lake
HealaFlow can be used in all types of glaucoma filtering surgeries:
• Trabeculectomy
• Deep Sclerectomy
• Viscocanalostomy
• Shunts/stents/tubes
1 | Penetrating surgery · Fig. 1
During conventional Trabeculectomy...
• Standardized Trabeculectomy with or without MMC.
• Application of HealaFlow underneath the flap with preplaced releasable suture.
• HealaFlow is injected while pulling back the canula.
• Avoid injection into the anterior chamber.
• Application of HealaFlow between sclera and conjunctiva.
• After delicate closure of the conjunctiva, a larger amount of HealaFlow
• is injected to create a subconjunctival space for future bleb formation.
2 | Non-penetrating surgery · Fig. 2
HealaFlow is indicated during non-penetrating surgery,
Deep Sclerectomy or Viscocanalostomy.
HealaFlow is injected under the first scleral flap in order
to maintain a patent scleral lake and filtering bleb.
• Application before suturing scleral flap · Fig.3
• Light suture tightening to avoid too much outflow resistance
• in the first postop days.
• Do not inject HealaFlow near the Descemet’s membrane to prevent rupture.
• Additional injection underneath the scleral flap after
• light suturing of scleral flap.
• After suturing verify that no gel is coming out of the borders.
• HealaFlow injection under the conjunctiva to seperate the tissue
• and create a large subconjunctival bleb · Fig.4
GLAUCOMA FILTERING SURGERIES3
Nature Abhors a Vacuum 03
Fig. 2Non-penetrating surgery
Fig.3 Under the scleral flap
Fig.4 Under the conjunctiva
Fig. 1 Penetrating surgery
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HEALAFLOW RETROSPECTIVE STUDIES4
Nature Abhors a Vacuum
Trabeculectomy
Professor J. Stuermer
Winterthur · Switzerland
50 cases between
May 2008/February 2009
50 eyes /50 patients
28% males /72% females
Mean age 70.7 years (41-88)
All caucasian origin.
Deep Sclerectomy
Professor A. Mermoud
Lausanne · Switzerland
19 difficult cases between
July 2008/February 2009
19 eyes/ 18 patients
55% males /45% females
Mean age 61.7 years (14-88)
94% caucasian origin.
Viscocanalostomy
Dr. G. Sunaric Mégevand
Geneva · Switzerland
40 cases between May
2008/February 2009
40 eyes/40 patients
25% males /75% females
Mean age 72 years (46-92)
95% caucasian origin.
POAG
Pseudo-exfoliative G
Ice-syndrome
Rieger/Axenfeld
Glaucoma type Cup/Disk ratio
1%
1%
22%
76%
2%
16%
82%
Glaucoma type Cup/Disk ratio
5%
5%
16%
11%
42%
21%
10%
16%
74%
Glaucoma type Cup/Disk ratio
16%
37%
43%
4%
2%
32%
66%
0.30 – 0.59 0.60 – 0.79 >= 0.80
POAG
PACG
Pseudo-exfoliative G
Disgenetic
0.30 – 0.59 0.60 – 0.79 >= 0.80
POAG
PACG
Pseudo-exfoliative G
Congenital G
Traumatic G
Ocular hypertension
0.30 – 0.59 0.60 – 0.79 >= 0.80
04
Nature Abhors a Vacuum 05
HEALAFLOW RETROSPECTIVE STUDIES4
IOP results Postoperative IOP evolution
IOP results
IOP results
Complications: 4 IOP spike, all were treated by release of releasable suture and massage. No iris incarceration.
Complications: 1 Postop hypotony (reformation of AC). 1 IOP spike on day one due to HealaFlow in AC (AC wash out). 1 Iris incarceration (laser pupilloplasty).
Complications: There was no complication after viscocanalostomy in these 40 eyes.
Bleb formation is not mandatory in viscocanalostomy but was found in the majority of cases as HealaFlow could spread from the scleral cavity under the conjunctiva.
Postoperative IOP evolution
Preop IOP (mm Hg)
Preop number of
glaucoma medication
Last postop IOP (mm Hg)
Follow-up time (weeks)
Diffuse filtration bleb
(% of patients)
Preop IOP (mm Hg)
Preop number of
glaucoma medication
Last postop IOP (mm Hg)
Follow-up time (weeks)
Very shallow bleb
(% of patients)
Preop IOP (mm Hg)
Preop number of
glaucoma medication
Last postop IOP (mm Hg)
Follow-up time (weeks)
MEAN
22.6
2.7
11.2
28
SD
6.5
0.9
4.8
8
MIN
12
1
3
0.2
MAX
40
4
22
36
MEAN
19.4
2.3
11.3
15.6
94%
SD
5.2
1.2
3.6
10.1
MIN
12
0
6
4
MAX
34
5
18
31
MEAN
22.4
2.9
11.3
21.2
87%
SD
5.4
0.7
3.3
11.3
MIN
14
1
4
4
MAX
33
4
24
36
all but 1 patient
all but 5 patients
25
20
15
10
5
0
25
20
15
10
5
0
1 day 1 week 1 month 3 months 5 months 10 months
IOP(mmHg)
preop
Postoperative IOP evolution
0 20 40 60 80 100 120 140 160 180 Days
IOP(mmHg)
200 40 60 80 100
IOP(mmHg)
Days
35
30
25
20
15
10
5
0
HEALAFLOW UBM IMAGES5
Nature Abhors a Vacuum
Patient 1
Conjunctival bleb
and UMB image
6 weeks after
Patient 2
Conjunctival bleb
and UMB image
16 weeks after
Patient 3
Conjunctival bleb
and UMB image
25 weeks after
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Prominent subconjonctival bleb Subconjonctival bleb
Prominent subconjonctival bleb Subconjonctival bleb
Intrascleral bleb
Subconjonctival bleb
Intrascleral bleb
Prominent subconjonctival bleb
Pictures by Prof. Mermoud · Lausanne06
1 | HEALAFLOW
3 | IMPROVES RESULTS OF GLAUCOMA SURGERY
2 | HEALAFLOW
3 | ACTS AS A LONG-TERM-SPACE-MAINTAINER
3 | HEALAFLOW
3 | INHIBITS INFLAMMATION AND
3 | FIBROSIS AT THE SURGIGAL SITE
4 | HEALAFLOW
3 | IS EASY TO HANDLE
To evaluate the efficiency of HealaFlow in glaucoma surgery, we are currently
setting up a prospective and randomized clinical trial in Switzerland.
Multicenter study (3 sites)
• Trabeculectomy: Prof. Joerg Sturmer (Winterthur)
• Deep Sclerectomy: Prof. André Mermoud (Lausanne)
• Viscocanalostomy: Dr. Gordana Sunaric Mégevand (Genève)
For more information
Please contact Ms Carole Scheibli: [email protected]
HEALAFLOW CONCLUSIONS6
Nature Abhors a Vacuum 07
HEALAFLOW NOTES7
Nature Abhors a Vacuum08
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Anteis OphthalmologyChemin des Aulx 181228 Plan-les-OuatesGeneva/Switzerland
Tel: +41 (0)848 949 848Fax: +41 (0)848 949 [email protected]
DP02-16/01EN
SwissCompany
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