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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
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