massmedic presentation 03-28-06 innovation accelerated sm
TRANSCRIPT
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MassMedicPresentation03-28-06
Innovation Accelerated SM
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Innovation Accelerated SM
CorNova, Inc.
Company Overview
Offices Corporate Headquarters – Burlington, MA
CorNova GmbH – Munich, Germany
CorNova Latin America – Buenos Aires, Argentina
Public Partners
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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
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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
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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
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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
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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
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Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
“The Pitiful Polymer”, John Orniston, MD, Dec 6, 2005
TaxusCypher
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Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
Taxus
“The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005
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Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
“The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005
Balloon Expansion
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Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
“The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005
Bifurcation
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Innovation Accelerated SM
CorNova, Inc.
Drug-Eluting Stents
CorNova’s DES
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Innovation Accelerated SM
CorNova, Inc.
EU Regulatory
Competent Authority(country specific under EN guidelines)
Notified Body(engaged by company)
Company(ISO 13485)
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Innovation Accelerated SM
CorNova, Inc.
Regulatory
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Innovation Accelerated SM
CorNova, Inc.
Regulatory
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Innovation Accelerated SM
CorNova, Inc.
Company Overview
ISO 13485 CertificationDecember 2005
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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?
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Innovation Accelerated SM
CorNova, Inc.
Regulatory
Drug Authority(country specific)
Notified BodyCompany
Dossier
Approval /Response
Consultation!!!
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Innovation Accelerated SM
CorNova, Inc.
Regulatory
FDA
Company
Dossier
Notified Body
DesignHistory File
ISO 13485 vs Design Control Guidance & Good Manufacturing Practice
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Innovation Accelerated SM
CorNova, Inc.
Company Overview
Thank You