H E A L A - Domedics AG · HealaFlowisaslowlyresorbablecrosslinkedviscoelasticgelindicated forpenetratingandnon-penetratingglaucomasurgery.Injectedunder thescleralflapandconjunctiva

H E A L ACROSSLINKED HA GLAUCOMA INJECTABLE IMPLANT

Anteis Ophthalmology

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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]

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