EPoSS - 28 September 2012, Paris

Workshop on the

Medical Devices Aspect of Micro-Nano-Bio Systems

« Market & Roadmaps for Electroactive Polymer or

1

« Market & Roadmaps for Electroactive Polymer or Gel in Implanted Medical Devices »

Dominique Delmas, Futurs Health Products, FR

MNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

Summary

• Market & Roadmaps for implantable Medical Devices with Smart Systems : How difficult is the prospective exercise !

• Electro-Active Gel (EAG) for vascular occlusion

2© EPoSS 2012 MNBS 2012, 3-4 May 2012, Athen

• Smart SystemTechnologies and EAG Devices roadmaps

• Market roadmap

• Design for “more” ; Design for “switch over”

MNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

Implantable Medical Devices Market & Roadmaps: How difficult is the prospective exercise !

Advanced

Market segment with

existing Medical Devices

Market segment with

Innovative Medical Devices

Enlarge Market segment

3© EPoSS 2012 MNBS 2012, 3-4 May 2012, AthenMNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

Advanced

Smart Systems

& MNBS

technologies

Enlarge Market segment thanks to the extension

of clinical application

New Market segment addressed thanks to additional

Advanced Smart Systems And/or multiplex integration

Breakthrough Markets

� Whatever the kind of prospective studies, there are always

– general rules and trends,

– but also disrupted incentives and unexpected opportunities

=> However, evolving environment and unsuspected events bring big and valuable challenges for people who are

Implantable Medical Devices Market & Roadmaps: How difficult is the prospective exercise

4© EPoSS 2012 MNBS 2012, 3-4 May 2012, Athen

bring big and valuable challenges for people who are prepared and attentive

� Let us try to be prepared.

=> Take the example of the Electro Active Gel (EAG) for

Vascular Occlusion.

MNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

� What is an electro-active gel (EAG) ?

EAG is a polymer made with

– Monomer material (e. g: pluronic acid)

– With cross linking polymerization / reticulation (covalent bonds)

– Positively charged allowing swelling by electro-activation

Electro-Active Gel (EAG) for vascular occlusion

5© EPoSS 2012 MNBS 2012, 3-4 May 2012, Athen 5

Electric field

(Low voltage (≤ 1V), large current (102 mA)

pH,

Salt concentration

TemperatureCollapsed state

High chain density

Swollen state

Volume X 10 up to 50

Low chain density &

high volume solvant

MNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

Electro-Active Gel (EAG) for vascular occlusion

� How do we use electro-active gel for vascular occlusion ?

– The objective is to use the material properties of the EAG to develop

6© EPoSS 2012 MNBS 2012, 3-4 May 2012, Athen

o minimal invasive cardiovascular procedures

o for closing, filling, or sealing off vessels or cavities

MNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

Electro-Active Gel (EAG) for vascular occlusion

� Vascular occlusion : Why perform vascular occlusion ?

– Excessive bleeding or hemorrhage (arteries, post sur surgery hemorrhage).

– Hypervascularized tumor

– Aneurysm and endoleak (Peripheral and intracranial aneurysm)

– Anatomic malformations

– Others clinical setting such as Uterine Fibroid and Varicocele

– Cardiac diseases : patients presenting atrium fibrillation or necessitating

7© EPoSS 2012 MNBS 2012, 3-4 May 2012, Athen

– Cardiac diseases : patients presenting atrium fibrillation or necessitating cardiac valves.

� How take care these clinical setting ?

– Depending on the case, open surgery … less and less done … too invasive

– Today, most of the cases are treated with transcatheter procedures : a “occlusion” device is implanted through a catheter introduced in a big vein or artery (femoral, )

� Transcatheter Embolization and Occlusion Procedures

� Transcatheter Embolization and Occlusion Devices

MNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

� Existing Transcatheter Embolization and Occlusion Device

PVA Micropheres

Embolization coils pushable, detachableexpandable hydrogel Embolic glue/liquid (Onyx)

Electro-Active Gel (EAG) for vascular occlusion

8© EPoSS 2012 MNBS 2012, 3-4 May 2012, AthenMNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

expandable hydrogel polymer coated or not

Plug devices (Amplatzer)

8

Embolic glue/liquid (Onyx)

Gelfoam, Drug eluting beads, Radio-embolization

?

� Some examples of Transcatheter Embolization procedures

Electro-Active Gel (EAG) for vascular occlusion

9© EPoSS 2012 MNBS 2012, 3-4 May 2012, AthenMNBS & Medical Devices ; the case of EAG - Paris 28 September 2012 9

Hemorrhage

Hypervascularized tumor

Aneurysm

� Transcatheter procedures : many different conditions

– Location : peripheral versus intra cranium

– Vessel diameters, shape, blood pressure at the target site

– Targeted objectives are various :

� Complete versus partial occlusion

� Urgent procedure or non urgent

Electro-Active Gel (EAG) for vascular occlusion

10© EPoSS 2012 MNBS 2012, 3-4 May 2012, Athen

� Long term versus short/middle term use

� Miscellaneous occlusion devices to cope with the different conditions. The choice of the TEO devices depends on

– Physicians practices (Surgeon, Interventional radiologist)

– Culture, country clinical history, training, country devices & procedures

– Devices selling prices compared to the clinical benefit

=> No overall consensus (some unsatisfied needs and side effects observed)

MNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

� Unmet needs versus expected breakthrough functionsToday Expected (ideally)

Many kinds of devices One kind of device, whatever the procedures

5 to 8 coils 8 to 10 device sizes (Amplatzer plug)

One deviceOne size

Customized occlusion: not yet reached Customized occlusion : shape, volume, pressure on the vessel wall

Procedure : device & operator dependant Standardized procedure

Electro-Active Gel (EAG) for vascular occlusion

11© EPoSS 2012 MNBS 2012, 3-4 May 2012, AthenMNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

Procedure : device & operator dependant Standardized procedure (lesser training, similar whatever the procedure)

Implantation at the targeted location :+/- controlled (pushable / detachable device)

Fully controlled at the targeted site (detachable,

retachable if relevant, …)

Blood clotting needed to get the occlusion (no anticoagulant can be used)

Occlusion by itself ; anticlotting authorized

Time to implantation : not optimized (~ 25 to 40 minutes or more)

Reduce time (by 20 to 50 %)

(Patient ; physician worked under fluoroscopy)

Coils, Amplatzer plug : not MR compatible MR compatibility

But, don’t forget : first, “non nocere” => full long term biocompatibility and stability

Occlusion Partial Occlusion

MNBS :EAG + EA delivery tool

MNBS :

EAG + EA delivery tool and

Smart SystemsTechnologies and EAG Devices

12© EPoSS 2012 MNBS 2012, 3-4 May 2012, Athen

EAG + EA delivery tool EAG + EA delivery tool and

Sensor 1

Sensor 2

T0 T0 + 2 to 3 years

MNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

Patients 75 000 (30% TEO) 75 000 (+ additional 30% TEO)

ASP ~ 900 € ~ 1 200 €(average selling price) (ASP coils/plug) (ASP coils/plug)

75 millions € (occlusion TEO) 75 millions € (occlusion TEO)

90 millions € (aneurysm TEO)

� Design for “more”

The anticipation of the clinical application road map should allow

- Optimizing the design of the first generation device

- Preparing, in parallel, the development of the adequate smart systems allowing the additional functions (technology PoC biocompatibility, packaging)

� Design for “switch over”

The anticipation of the Smart System based function, should allow

Conclusion

13© EPoSS 2012 MNBS 2012, 3-4 May 2012, Athen

The anticipation of the Smart System based function, should allow Identifying some breakthrough clinical applications, once the previous devices validated:

– Smart Systems- e.g. : Anchoring, pressure sensor, biomaterial stability, …

– Clinical Hypertension: Rebel hypertension

• Awareness and understanding of Smart Systems are a prerequisite

• Anticipation of the long term biocompatibility and stability of any material used should be kept in mind as soon as the first step of the technological PoC

MNBS & Medical Devices ; the case of EAG - Paris 28 September 2012

Thank You

14© EPoSS 2012 MNBS 2012, 3-4 May 2012, AthenMNBS & Smart Systems in Health sector, Paris 28 September 2012