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Slide Gallery Simple Slide Format AvA Aortic Valve Bypass Graft System.

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Presentation on theme: "Slide Gallery Simple Slide Format AvA Aortic Valve Bypass Graft System."— Presentation transcript:

1 Slide Gallery Simple Slide Format AvA Aortic Valve Bypass Graft System

2 Heart Valve Therapy Has Remained Unchanged Over the Last 30 Years Diseased Aortic Valve

3 Difficulty Tolerating Cardiopulmonary Bypass No Surgical Option High Mortality Risk Unserved Patient Population is Driving the Development of Alternative Treatments

4 Aortic Valve Bypass Graft (AVBG) Transcatheter Valve Patient PopulationsAVBG Transcatheter Valve Tricuspid XX Bicuspid X Coronary Artery Disease X Alternative Therapies under Development

5 AVBG Clinical History Human Experience On pump Non-standardized components Physiology works Reduced pressure gradients Normal coronary flow 20+ year survival 1910CarrelFirst Concept 1955SarnoffAnimal Series 1962TempletonFirst Human BrownHuman Series CooleyHuman Series 2003VassiliadesHuman Series GammieHuman Series

6 AvA Valve Bypass System AvA = A pex Valve A orta Access Tool Implant

7 How It Works 5 th ICS

8 AvA Aortic Valve Bypass System

9 AVBG Competitive Advantages Eliminates Heart-Lung Bypass Minimize Incision Reduce Complications Reduce Costs Reduce Hospital Stay Uses Established Heart Valve Long Implant History Surgeon Acceptance Broad Clinical Application Bicuspid or Tricuspid Coronary Artery Disease

10 Transcatheter Competition While the current operative mortality is too high, it is improving and with hundreds of millions of dollars being invested, its hard to bet against them. Edwards LifeScience est. $350 MM development program Medtronic est. $1.2 B development program Other Start-ups est. $250 MM Est. Total Transcatheter Investment – $1.8 Billion Anonymous venture capitalist

11 Does not fit Into bicuspid shaped valves Dislodges particles to brain Prevents future coronary interventions Disrupts Heartbeat Transcatheter Competition 40 % of pts. over age 70 have a bicuspid valve % Stroke Rate 65 % of pts. over age 70 with a stenotic tricuspid valve have CAD % Pacemaker implantation While the current operative mortality is too high, it is improving and with hundreds of millions of dollars being invested, its hard to bet against them. Est. Total Transcatheter Investment – $1.8 Billion Anonymous venture capitalist

12 Transcatheter Competition

13 AVR Distribution by Age, Cusp, and CAD Data 932 consecutive AVR patients 1993–2004 Roberts, Circulation. 2005; 111:920–925

14 Cusp Type and/or CAD Prevalence in AVR pts. over age 70 AVBG Transcatheter Valve Bicuspid w/o CAD20%+ Contraindicated * Bicuspid w/CAD20%+ Contraindicated * Tricuspid w/o CAD21%++ Tricuspid w/ CAD39%+ Contraindicated * Alternative Therapies by Cusp Type and CAD Edwards LifeScience PARTNER Trial protocol European Association of Cardio-Thoracic Surgeons guidelines European Society of Cardiology guidelines * Patients with Bicuspids or Untreated Significant CAD are contraindicated for transcather valve implantaion Future CAD Intervention Bicuspid

15 Will Transcatheter procedures be applicable to broad market segment? AttributeNo CADCAD Tricuspid 21%39% Bicuspid 20% Key PARTNER Trial Exclusion Criteria: Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified Untreated clinically significant coronary artery disease requiring revascularization AVR Patients Age 70+ Data 932 consecutive AVR patients 1993–2004 Roberts, Circulation. 2005; 111:920–925

16 AvA Valve Bypass System A reasonable next step in aortic valve therapy A SAFER alternative for high risk aortic valve patients Something NEW combined with something PROVEN


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