Ultrasound glaucoma treatment A non-invasive alternative

TECHNICAL SPECIFICATIONS

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Finger grip

Therapy probe

Ciliary body

Focal zone

Transducer

Positioning cone

Schematic cross section view

Set up of the probe and coneUCP - Ultrasound Ciliary Plasty

The UCP procedure, treatment of glaucoma utilizing ultrasound, is an innovative alternative to control intraocular pressure.

Fast and non-invasive, it is performed using a sterile, single-use procedure pack composed of a therapy probe and a positioning cone. The latter are connected to the EyeOP1® control unit in order to program and monitor the treatment parameters.

The procedure pack

The therapy probe is composed of six piezoelectric transducers spread around the circumference. The device comes in three sizes to account for differences in ocular anatomy thereby enabling accurate targeting. The dose of ultrasound thus delivered preserves adjacent tissues.

The design of the positioning cone allows for optimal centration and positioning on the eye.

The EyeOP1® control unit

Compact, user-friendly and very simple to use, the EyeOP1® module generates the ultrasound energy during the procedure.

The touch-screen user interface enables the operator to safely parameter and monitor the treatment. The simple tree structure allows for intuitive use.

EYEOP-PACK - Single-use procedure pack

THERAPY PROBESix piezoelectric transducersSizes available: 11, 12 and 13 mm(Product SKU Nos.: ETC0911, ETC0912 and ETC0913)

POSITIONING CONETransparent and biocompatible PMMATwo suction pointsTarget vacuum level: 225 mmHg (external)

EyeOP1® - Control unit

Frequency 21 MHz

Acoustic power 3 wattsCompact control unit Vacuum and ultrasound generation functions Mains supply 110 – 230 V, 50/60 Hz, 150 VACommand pedal Dual function: suction and firingTouch screen Intuitive user interface

Built-in thermal printer Automatic print out of the treatment report. Additional prints on request

Dimensions (cm) 36 (L) x 32 (W) x 26 (H), portable

Weight without/with transport case (Kg) 7/14

Ultrasound focused into the ciliary body

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UCP is the only medical procedure that addresses all patients with uncontrolled glaucoma irrespective of their prior treatment history

Simple, accurate and reproducible, the treatment is performed in just under three minutes, without incisions

2871, Avenue de l’Europe 69140 Rillieux-la-Pape - FRANCETel: +33 (0)4 78 88 09 00Fax: +33 (0)4 78 97 45 11

www.eyetechcare.com

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Carefully read the instructions before using this product

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Therapeutic Ultrasound

A transformation in glaucoma careGentle, safe, swift, effective

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Ultrasound Cyclo PlastyUCP

The innovative solutionHigh-intensity focused ultrasound (HIFU) creates varying levels of focused energy. The technology is commonly used in numerous other medical specialties, including treatment of certain cancerous tissues and tumours.

EYE TECH CARE has adapted this technology to the field of ophthalmology and gone several steps further by developing specialised and unique miniaturised transducers that can deliver HIFU in the eye with high precision for glaucoma treatment.

• Adaptable to a broad spectrum of patients, from moderate stage patients under maximal hypotensive medication when surgery is at risk, to more advanced-stage patients1,2.

• Can be used in the care of open angle and angle closure glaucoma3.

• Allows patients a swift return to their functioning daily lives with light follow-up1.

A new vision in glaucoma care EYE TECH CARE is a dynamic medical device company that aims at transforming glaucoma care in an innovative way with the use of Therapeutic Ultrasound. The company is passionate in the belief that Therapeutic Ultrasound has far-reaching benefits to offer for both clinicians and patients.

The conditionGLAUCOMA affects

of the world’s population over the age of forty4.

2ndGLAUCOMA is the leading cause of blindness worldwide5.

people world wide will be blind due to glaucoma by 20206.

11million

MILD MODERATE ADVANCED

HIFU waves emitted from a circular array of 6 miniaturized transducers at a frequency of 21 Mhztargeting less than 40% of the ciliary body.

TREATMENT SPECTRUM OF UCP

STAGES OF GLAUCOMA

Transforming patient care

Due to its silent progression, up to of affected people in developed countries and in emerging countries are not aware they have glaucoma.6

50%

90%

3%

Ultrasound Cyclo PlastyUCP

1 Reshaping of the ciliary body structure, decreasing aqueous humour inflow7.

2 Local opening of the uveoscleral pathway increasing aqueous humour outflow7,8.

Contributing to a lowering of the intraocular pressure.

CILIARY BODY RESHAPING

LOCAL OPENING OF THE UVEOSCLERAL PATHWAY

Ciliary body

Vitreous body

Lens

Iris

Cornea

Sclera

Schlemm’s canal

Trabecular meshwork

Aqueous humor inflow

Trabecular outflow

Uveoscleral outflow

Main mechanisms of action

UNTREATED

Secretion of aqueous humor via epithelial cells in the ciliary body9

TREATED

Epithelial cells removed but blood-aqueous barrier preserved9

UNTREATED TREATED

After UCP treatment an opening is observed between sclera and ciliary body10

Ultrasound Cyclo PlastyUCP

The clinical results

4000 patients11

No phthisis bulbi, induced cataract, or persistent hypotony were recorded across 7 clinical studies1.

% o

f pat

ient

s

% o

f IO

P re

duct

ion27% >40%

>30%

>20%

51%

64%

Safety results

Without additional hypotensive treatment - 110 patients after 1 UCP treatment - 8 patients lost to follow-up

RESPONSE LEVELS AT 6 MONTHS12

00 10 20 30 40

10

20

30

40

IOP

6 m

onth

s (m

mH

g)

IOP baseline (mmHg)

DISTRIBUTION OF IOP VARIATION1

A metaanalysis, including 7 peer-reviewed clinical papers and 251 patients, highlights the good safety profile and efficacy1.

has been used worldwide to treat more than

AVERAGE IOP REDUCTION AT 6 MONTHS1

35%

Efficacy results

Ultrasound Cyclo PlastyUCP

The difference

• UCP utilises computer-assisted technology resulting in a controlled treatment with high reproducibility and quick learning curve.

• UCP is a non-invasive procedure, limiting risks of infection.

• UCP can address patients with uncontrolled glaucoma, irrespective of their prior treatment history.

• A second UCP treatment or other treatment options are still possible if needed after an initial UCP procedure1.

Ultrasound Cyclo PlastyUCPThe benefits

High reproducibility

Short learning curve

Good tolerance profile

Quick recovery time

Eased postoperative care

References1. Denis P, Clinical Research of Ultrasound Ciliary Plasty and

Implications for Clinical Practice, European Ophthalmic Review, 2016;10(2):108–12

2. Denis P, Aptel F, Rouland JF, Renard JP, Bron A, Multicenter clinical trial of high-intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery; Acta Ophthalmol., 2015; Nov 7 [epub ahead of print]

3. Indications/User manual

4. Tham Y, et Al, Global Prevalence of Glaucoma and Projections of Glaucoma Burden through 2040, Ophthalmology, 2014, Vol.121 (11):2081-90

5. www.who.int/bulletin/volumes/82/11

6. www.iapb.org/vision-2020

7. Aptel F, Denis P, Ultrasonic Circular Cyclocoagulation, Surgical innovations in glaucoma, 2014, 40(9):2096-2106

8. Mastropasqua R, et Al, Uveoscleral outflow pathway after ultrasonic cyclocoagulation in refractory glaucoma: an anterior segment optical coherence tomography and in vivo confocal study, British Journal of Ophthalmology, 2016, 100(12):1668-1675

9. Aptel F, et Al, Short- and long-term effects on the ciliary body and the aqueous outflow pathways of high-intensity focused ultrasound cyclocoagulation, Ultrasound Med Biol., 2014; 40(9):2096-106

10. Aptel F, et Al, Miniaturized high-intensity focused ultrasound device in patients with glaucoma: a clinical pilot study, Invest Ophthalmol Vis Sci., 2011; 52(12):8747-53. doi: 10.1167/iovs.11-8137

11. Internal database - updated Feb 17

12. Internal metaanalysis database - Dec 15

EYE TECH CARE 2871 avenue de l’Europe, 69140 Rillieux-La-Pape FRANCE

www.eyetechcare.com BRO_MKT_008_EN/05 2017

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