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PMN 286 Rev A
E L I X I R M E D I C A L C O R P O R A T I O N
INNOVATINGVA S C U L A R R E S T O R AT I O N TM
Pipeline
Elixir
Bioresorbable Scaffold Therapy – Why ?Bioresorbable Scaffold Therapy – Why ?
Our Technology - DESolveOur Technology - DESolve
PMN 286 Rev A
ABOUT ELIXIR ®
E L I X I R M E D I C A L C O R P O R A T I O N 3
Elixir was founded in 2005and is located in Sunnyvale, California.
10Years
Elixir has consistently demonstrated the ability to out-engineer and out-innovate
traditional large companies.
PMN 286 Rev A
ABOUT ELIXIR ®
E L I X I R M E D I C A L C O R P O R A T I O N 4
20+Countries
Present in over 20 countries. Uninterrupted product supply.
CorporateHeadquarters
PMN 286 Rev A
ABOUT ELIXIR ®
3 Industry Encompassing Categories:
E L I X I R M E D I C A L C O R P O R A T I O N 5
Drug Eluting Stent (DES)1 ®
Drug Eluting Stent with Biodegradable Polymer Coating2 ®
Drug Eluting Bioresorbable Scaffold (BRS)3®
DESolve, DESyne BD and DESyne are CE Mark approved. Not available for sale in the U.S.DESolve, DESyne BD and DESyne are registered trademarks of Elixir Medical.
PMN 286 Rev A
E L I X I R M E D I C A L C O R P O R A T I O N 6
Bioresorbable Scaffold Therapy – Why ?
PMN 286 Rev A
PMN 286 Rev A
REVASCULARIZATION –EVOLUTION OF CORONARY STENTS
E L I X I R M E D I C A L C O R P O R A T I O N 7
*Fajadet Our Interventional Future PCR 2010
ANGIOPLASTY
1977 1986 1999 Today
Revascularization
Allows for natural arterial function
Restenosis (20% to 30%),* Recoil, Subacute thrombosis
PMN 286 Rev A
REVASCULARIZATION –EVOLUTION OF CORONARY STENTS
E L I X I R M E D I C A L C O R P O R A T I O N 8
*Fajadet Our Interventional Future PCR 2010
1977 1986 1999 Today
BARE METAL STENTS
Revascularization
Prevention of acute arterial recoil
Restenosis (15% to 50%),* injury to the endothelium may cause acute stent thrombosis
Permanent implant
PMN 286 Rev A
REVASCULARIZATION –EVOLUTION OF CORONARY STENTS
E L I X I R M E D I C A L C O R P O R A T I O N 9
1977 1986 1999 Today
DES
Revascularization
↓ Restenosis rate (10%)*
Long-term DAPT required
Late stent thrombosis
*Fajadet Our Interventional Future PCR 2010
Permanent implant
PMN 286 Rev A
BIORESORBABLE SCAFFOLDS
E L I X I R M E D I C A L C O R P O R A T I O N 10
1977 1986 1999 Today
Scaffold provides best-in-class DES drug elution
Short-term support is sufficient for acute gain and prevention of recoil
BRS MECHANICAL BENEFITS – DESIGN GOALS
Uncaging in a timely manner
PMN 286 Rev A
11E L I X I R M E D I C A L C O R P O R A T I O N 11
BIORESORBABLE SCAFFOLDS –
“UNCAGING” THE ARTERY
BIOLOGICAL BENEFITS
After resorption – no foreign body *
OTHER BENEFITS
Keep options open• CABG • Re-intervention
PMN 286 Rev A
Return of flexibility in artery for pulsatile flow
Return of vasomotion (ability of artery to contract/expand in response to hormonal influences)
PMN 286 Rev A P M N 2 4 7 R e v A
PLLA-based material with excellent durability, flexibility, proven biocompatibilityProfile: 150 µmDegrades in one year, resorbs in 2 yearsGood Radial strength, low acute recoilLow drug dose of Novolimus
Engineered to fulfill the promise of BRS
DESolve® BIORESORBABLE CORONARY SCAFFOLD
PMN 286 Rev A
DESolve® PERFORMANCE CRITERIA
FOR A FULLY B IORESORBABLE DEVICE
E L I X I R M E D I C A L C O R P O R A T I O N 14
Forrester JS, et al., J. Am. Coll. Cardiol. 17, 758 (1991)Oberhauser JP, et al., EuroInterv. 5, F15 (2009)DESolve is CE Mark approved. Not available for sale in the U.S.
1month 3 m 6 m 12 m 24 m
Drug Elution
Polymer Molecular
Weight Polymer Mass
PMN 286 Rev A
PMN 286 Rev A
DESolve® BIORESORBABLE CORONARY SCAFFOLD
EXCELLENT VESSEL CONFORMABILITY
E L I X I R M E D I C A L C O R P O R A T I O N 15
Case from A Abizaid, D Chamie, Instituto Dante Pazzanese, TCT 2012
97o
DESolve3,5 x 14mm DESolve (92o)
18 monthsPost-placementAt placementPre-placement
DESolve is CE Mark approved. Not available for sale in the U.S.
PMN 286 Rev A
MAIN BRANCH POST D ILATATION AND FRACTURE RESISTANCE
E L I X I R M E D I C A L C O R P O R A T I O N 16
*J Ormiston, TCT 2014Absorb is a registered trademark of Abbott Vascular.DESolve is CE Mark approved. Not available for sale in the U.S.
PMN 286 Rev A
UNDEREXPANSION: DESo lve ®
SELF-CORRECTION TO NOMINAL D IAMETER
E L I X I R M E D I C A L C O R P O R A T I O N 17
Data on file at Elixir Medical.Absorb is a registered trademark of Abbott Vascular.DESolve is CE Mark approved. Not available for sale in the U.S.
Pre-PCI Post-PCI 6-Month FU 18-Month FU 36-Month FU
C o u r t e s y o f D r . A . A b i z a i d , I n s t i t u t o D a n t e P a z z a n e s e d e C a r d i o l o g i a
S ã o P a u l o , B r a z i l
DESolve® DIFFERENTIATING PERFORMANCE CHARACTERISTICS
PMN 286 Rev A
DESolve Pipel ine
E L I X I R M E D I C A L C O R P O R A T I O N 21
* MRVD ≥3.75 – 4.00mm^ J. Ormiston et al, An independent bench comparison of two bioresorbable drug-eluting coronary scaffolds (Absorb and DESolve) with a durable metallic drug-eluting stent (ML8/Xpedition), EuroIntervention 2015;10-online publish-ahead-of-print February 2015.‡ Not to exceed .5mm beyond scaffold diameter.
DESolve and DESolve 100 are CE Mark approved. Not available for sale in the U.S.
Advancing BioresorbableScaffold Technology
PMN 286 Rev A
DESolveDESolve 100
DESolve100: Bioresorbable Coronar y
Scaf fold with 100µm strut thickness
CE mark approvedCurrently in clinical evaluationExpected launch in H2’2015
OCT analysis in porcine coronary model post implant
PMN 245
PMN 286 Rev A
DESolve Coronar y Scaf folds
In DevelopmentCE Mark ApprovedCE Mark Approved
Available in 4.0mm diameter
Drug-eluting
Bioresorbable scaffold
DESolve FIMDESolve Nx
Dose: 5 µg/mm ofStent or Scaffold length
NovolimusPharmaceutical
Biodegradable polymer coating
Bioresorbable scaffold
Biodegradable polymer coating
Bioresorbable scaffold
PMN 286 Rev A
� First in Man Clinical Trial Planned for 2nd half 2015
Bioresorbable SFA Scaf fo ld
Design
Elixir SFA Covidien Protégé Everflex
Cook Zilver PTX
Radial Strength1
Elixir SFA Covidien Protégé Everflex
Cook Zilver PTX
Scaffold Stiffness1
More
conformable
1. Data on file at Elixir Medical, 1190-029N
Post Implant 1 Month 3 Month 6 Month
PMN 286 Rev A
VascularVascular
CarotidCarotid NeuroNeuro VenousVenous
NonvascularNonvascular
ENTENT PulmonaryPulmonary
El ix i r Is Pur su ing Other Ind icat ions
Outs ide o f Coronar y and Per iphera l
Currently in market research / market requirement definition phaseDevelopment efforts will begin in 2015 on the first of these indications
PMN 245Note: Pursuing development through license to Aigle and Cerona Medical