Vulnerable Plaque

1
Innovation Accelerated SM
MassMedicPresentation03-28-06
2
Company Overview
Offices

• Corporate Headquarters Burlington, MA
• CorNova GmbH Munich, Germany
• CorNova Latin America Buenos Aires, Argentina

Public Partners
3
Drug-Eluting Stents
Drug-Eluting Stents

• 5 Billion Market (4.5M DES deployed)
• DES 10x price of bare stent system in Europe
• Cypher (Cordis) Taxus (Boston Scientific) only
  currently approved devices in US
• 2nd Gen in Europe - Cypher-Select (Cordis)
  Taxus Liberte (Boston
  Scientific) Host
  of others (-limus family)
• Issues for current DES (especially in certain
  subsets)- Remaining Restenosis- Stent
  Thrombosis- Unapproved Indications
  

4
Drug-Eluting Stents
Restenosis (TLR)
Evidence-based medicine guidelines for
drug-eluting stent use, Greg Stone,
Cardiovascular Research Foundation
5
Drug-Eluting Stents
Stent Thrombosis
Evidence-based medicine guidelines for
drug-eluting stent use, Greg Stone,
Cardiovascular Research Foundation
6
Drug-Eluting Stents
Stent Thrombosis
Milan/Siegburg Experience (Lakovou et al, JAMA
20052932126-2130)
7
Drug-Eluting Stents
Unapproved Indications

• Bifurcations
• Long lesions
• Chronic total occlusions
• Left main disease
• In-stent restenosis
• Multivessel disease
• Acute MI

Evidence-based medicine guidelines for
drug-eluting stent use, Greg Stone,
Cardiovascular Research Foundation
8
Drug-Eluting Stents
Taxus
Cypher
The Pitiful Polymer, John Orniston, MD, Dec 6,
2005
9
Drug-Eluting Stents
Taxus
The Pitiful Polymer, John Orniston,MD, Dec 6,
2005
10
Drug-Eluting Stents
Balloon Expansion
The Pitiful Polymer, John Orniston,MD, Dec 6,
2005
11
Drug-Eluting Stents
Bifurcation
The Pitiful Polymer, John Orniston,MD, Dec 6,
2005
12
Drug-Eluting Stents
CorNovas DES
13
EU Regulatory
Competent Authority (country specific under EN
guidelines)
Notified Body (engaged by company)
Company (ISO 13485)
14
Regulatory
15
Regulatory
16
Company Overview
ISO 13485 Certification December 2005
17
EU Regulatory
Dossier (I, Is, IIa, IIb, III device)
Company
Notified Body
Consultation?
Prior 2006
Approval / Response
Drug Authority (country specific)
18
Regulatory
Dossier
Company
Notified Body
Consultation!!!
Approval / Response
Drug Authority (country specific)
19
Regulatory
Company
Design History File
Dossier
Notified Body
FDA
ISO 13485 vs Design Control Guidance
Good Manufacturing Practice
20
Company Overview
Thank You