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MassMedicPresentation03-28-06
Innovation Accelerated SM
Innovation Accelerated SM
CorNova, Inc.
Company Overview
Offices Corporate Headquarters – Burlington, MA
CorNova GmbH – Munich, Germany
CorNova Latin America – Buenos Aires, Argentina
Public Partners
Innovation Accelerated SM
CorNova, Inc.
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
Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
Restenosis (TLR)
Combined Cypher Studies
At 36 months
Cypher
6.4%
Bare
23.2%
Combined Taxus Studies
At 36 months
Taxus
9.4%
Bare
19.9%
“Evidence-based medicine guidelines for drug-eluting stent use”, Greg Stone, Cardiovascular Research Foundation
Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
Stent Thrombosis
Combined Cypher Studies
At 36 months
Cypher
1.1%
Bare
0.6%
Combined Taxus Studies
At 36 months
Taxus
1.3%
Bare
0.8%
“Evidence-based medicine guidelines for drug-eluting stent use”, Greg Stone, Cardiovascular Research Foundation
Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
Stent Thrombosis
Milan/Siegburg Experience (Lakovou et al, JAMA 2005;293:2126-2130)
0%
1%
2%
3%
4%
5%
6%
All Patients Diabetes Bifurcation Renal Failure
Innovation Accelerated SM
CorNova, Inc.
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
Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
“The Pitiful Polymer”, John Orniston, MD, Dec 6, 2005
TaxusCypher
Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
Taxus
“The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005
Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
“The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005
Balloon Expansion
Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
“The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005
Bifurcation
Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
CorNova’s DES
Innovation Accelerated SM
CorNova, Inc.
EU Regulatory
Competent Authority(country specific under EN guidelines)
Notified Body(engaged by company)
Company(ISO 13485)
Innovation Accelerated SM
CorNova, Inc.
Regulatory
Innovation Accelerated SM
CorNova, Inc.
Regulatory
Innovation Accelerated SM
CorNova, Inc.
Company Overview
ISO 13485 CertificationDecember 2005
Innovation Accelerated SM
CorNova, Inc.
EU Regulatory
Drug Authority(country specific)
Notified BodyCompany
Prior 2006
Dossier (I, Is, IIa, IIb, III device)
Approval /Response
Consultation?
Innovation Accelerated SM
CorNova, Inc.
Regulatory
Drug Authority(country specific)
Notified BodyCompany
Dossier
Approval /Response
Consultation!!!
Innovation Accelerated SM
CorNova, Inc.
Regulatory
FDA
Company
Dossier
Notified Body
DesignHistory File
ISO 13485 vs Design Control Guidance & Good Manufacturing Practice
Innovation Accelerated SM
CorNova, Inc.
Company Overview
Thank You
