History of cardiology

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Slide 1 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Device Development: Past, Present and Future 1

Slide 2 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine MY CONFLICTS OF INTEREST ARE

Slide 3 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Approaches to Establish Funding Angel Venture Corporate 2

Slide 4 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Angel Funding Pros Less Expensive Industry Expertise Provides Upstart to build value and more leverage Cons: Hassle Factor One/Two Round Only When does it make sense? Less Cash intensive opportunities Low regulatory hurdles Fast-followers First-timers putting an experienced executive team together 3

Slide 5 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Venture Funding Pros Deep Pockets Professional Expertise Extensive Business Network Cons More Expensive Return / Liquidity Requirements In-Depth Due Diligence When does it make sense? Large Opportunities Markets > $500 million Cash and time intensive First-timers unable to assemble a solid executive team together 4

Slide 6 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Corporate Funding Pros: Less Expensive Value Add Credibility Cons: Hidden Agenda/Special Rights Questionable Follow-On Dollars Exit Strategy Limited Business Alignment When does it make sense? Funding Needs beyond VC’s Close to commercialization…looking for a commercial partner 5

Slide 7 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Funding Stages Company Stage Concept Company Sales / Profits Liquidity Product Devt and Commercialization 6

Slide 8 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Important Startup Rule #1 The more $$ you spend The more $$’s you have to raise The more of your opportunity you have to sell The less return you provide to investors… 7

Slide 9 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine The Team & The Company Management: Do You Have a CEO? Is He/She Qualified, Experienced as CEO? Can They Raise Money? Team: Functional Disciplines? No-compromise on hiring great people? Team Chemistry? Bottom Line: Risk in the team….COSTLY The timing of the right functional teams coming together ….CRITICAL TO SUCCESS 8

Slide 10 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Intense Competition Intellectual Property Capital Requirement Engineering Regulatory Environment 9

Slide 11 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Anatomy of a Start-up… IPO FDA Approval; Product Launch Distribution Agreement Hired CEO; Key management in place FDA submission Animal studies completed; Start clinical trials Prototype completed; Funds raised Patents Disclosed Time (years) Valuation ($) 10

Slide 12 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Timing is everything It is often, but not always best to be first Some markets change quickly; others very slowly New market development is expensive Window of Opportunity 11

Slide 13 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Rigor of randomized clinical trials Clinical adoption Ease of use Learning curves 12

Slide 14 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Goals of Startups Balancing 13

Slide 15 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Understanding of the Opportunity 14

Slide 16 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Golden Rules Device or procedure must be simple to apply an can be adopted by the average practitioner Invention addresses an otherwise unmet clinical need Device regulatory path is associated with a “reasonable” chance for success in an otherwise well defined study with a finite sample size

Slide 17 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005 2006 16

Slide 18 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977

Slide 19 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Coronary Angioplasty (PTCA) Andreas Gruntzig

Slide 20 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984

Slide 21 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Directional Coronary Atherectomy (DCA) John Simpson

Slide 22 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984 1988

Slide 23 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Rotational Atherectomy (PTCRA) David Auth

Slide 24 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984 1988 1989

Slide 25 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Coronary Stenting Julio Palmaz

Slide 26 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984 1988 1989 1997

Slide 27 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine In- Stent Restenosis

Slide 28 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Brachytherapy

Slide 29 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000

Slide 30 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Drug Eluting Stents

Slide 31 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Event-Free Survival at Two Years following procedure Freedom from events (%) Days after initial procedure 92% 76%

Slide 32 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine ARTS I: Three-year outcome after Stenting vs. CABG for the Treatment of Multivessel Disease . 100 99 98 97 96 95 94 93 92 91 90 0 120 240 360 480 600 720 840 960 1080 1200 Days since randomization % Survival Stent CABG Van Domburg, et al., Circ. 2004:109, 1114-20

Slide 33 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Slide 34 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002

Slide 35 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Percutaneous Treatment of Carotid Artery Stenosis

Slide 36 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Percutaneous Aortic Valve Therapy Alain Cribier

Slide 37 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Percutaneous Valve Therapy Edwards LifeSciences

Slide 38 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Self-expanding Nitinol multi-level frame Porcine pericardium Tissue Valve Disposable Loading System Delivery Catheter 18 French 12 Fr body The CoreValve Revalving™ System Self-Expanding Support Frame

Slide 39 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Slide 40 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003

Slide 41 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Percutaneous “Mitral” Valve Repair Coronary Sinus Annuloplasty Edge-to-Edge Repair

Slide 42 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Coronary Sinus Annuloplasty Edwards LifeScience Handle Sliding Knob Location of Implant (Internal) Distal Anchor Proximal Anchor Bridge

Slide 43 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Mitral Valve Edge-to-Edge Repair

Slide 44 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004

Slide 45 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Atrial fibrillation is a major source of cardiogenic embolism-related stroke Source: Neurology, 1978; Stroke, 1985; European Heart Journal, 1987; Lancet, 1987 500,000 strokes per year AHA estimates that 15 – 20% of strokes/year are related to AF

Slide 46 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine WATCHMAN® Device Frame: Nitinol (shape memory) Contour shape accommodates most LAA anatomy Barbs engage the LAA tissue Fabric Cap: Polyethyl terephthalate (PET) Fabric Prevents harmful emboli from exiting during the healing process Barbs 160 µ PET fabric Device available in various sizes: 21, 24, 27, 30 and 33 mm (diameter) Device diameter is measured across face of device Device Length = Device Diameter

Slide 47 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Left Atrial Appendage Closure

Slide 48 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005

Slide 49 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine The Next Frontier in Coronary Stenting

Slide 50 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Treating Bifurcation Lesions Limitations of Current DES Stents are tubular structures not intended for Y-shaped anatomy Side branch jailing Limited ostial coverage (“Gaps”) Technically demanding Multiple layers of metal Increasing risk of thrombosis Myriad of Techniques Gap Multiple Layers

Slide 51 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine The TAXUS PetalTM Boston Scientific Coroporation Stent Advantages Special stent feature to cover ostium of side branch (~2mm) Reduces / eliminates side branch “gap” May reduce frequency of 2nd stent Placing 2nd stent, when necessary, is technically more straight forward Delivery System Advantages Side Branch wire lumen aids in alignment at ostium Side branch “pre-wired”, no need to re-access through stent Final Petal size determined by post dilatation balloon

Slide 52 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Chronic Total Occlusion (CTO) .

Slide 53 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005 2006

Slide 54 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Why Degradable Stents? No late adverse events Late thrombosis Hypersensitivity reactions (chronic inflammation) Stent fractures Does not restrict arterial remodeling Permits non-invasive imaging of artery Permits bypass surgery in future Degradable Stents

Slide 55 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Bioabsorbable Stent Design .

Slide 56 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Multi-Layer, Combination Drug Delivery

Slide 57 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Biodegradable Stents Could also be the ideal vehicle for several other applications: non-obstructive vulnerable plaque, gene transfer for infract repair and angiogenesis…..

Slide 58 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine “Biodegradable Stents: They Do Their Job and Disappear” Ron Waksman

Slide 59 :

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Future Opportunities in Interventional Cardiology Peripheral Vascularization -Claudication -Limb Salvage -Angiogenesis Structural Heart/ Stroke Prevention -PFO/ASD Closure -Left Atrial Appendage closure - Atrial Fib. Ablation Cerebral Revascularization -Carotid Stenting -Embolic Protection Devices -Acute Stroke Intervention Congestive Heart Failure -Resynchronization Therapy -Impulse Modulation -Implantable Pressure Regulators

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