Valvuloplasty Scoring Balloon for the Treatment of Critical Aortic Valve Stenosis - Design of a FIM Study - Gary Gershony, MD, FACC, FSCAI, FAHA, FRCPC Interventional Cardiologist, John Muir Cardiovascular Institute, Concord, CA Co-Founder and Chief Medical Officer, AngioScore, Fremont, CA

Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Consulting Fees/Salary Support AngioScore, Inc. Major Stock Shareholder/Equity Royalty Income Ownership/Founder AngioScore, Inc. Intellectual Property Rights Other Financial Benefit This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) 2 2

Valvuloplasty Scoring Balloon Rationale: More optimal and symmetric valvuloplasty may allow better seating/expansion during TAVI and reduce incidence of AI Provide improved results compared to conventional BAV as “stand alone” treatment or “bridge” to TAVI/SAVR Expand (≥30%) TAVI indications to include bicuspid AV (currently contra-indicated) More rapid deflation and superior re-wrap may improve safety and allow smaller size arterial access sheaths Avoid slippage during AV pre-dilatation and minimize risk of LV perforation by balloon catheter tip May preclude need for rapid RV pacing May also be useful in valvuloplasty of other valvular stenosis (e.g. mitral, pulmonic)

AngioSculpt – Coronary/Peripheral + = 2 component system OTW or rapid exchange semi-compliant balloon Laser cut nitinol spiral scoring element (0.005-0.007” struts) Available in 2.0 - 6.0 mm diameter, 10 - 100 mm length

AngioSculpt – Mechanical Forces Edges lock in ~15-25x force 1x force

Valvuloplasty Scoring Balloon Components 12-strut scoring element Two axis polymeric spring Catheter shaft Fixed proximal bond “Floating” intermediate bond Fixed distal bond The spiral element expansion is controlled by a combination of a fixed distal end and a semi-constrained proximal end

Valvuloplasty Scoring Balloon Design Excellent Balloon Re-Wrap Post-Deflation 18, 20, 22, 24 mm diameter x 4.0 cm length balloons, atraumatic soft tip Laser cut nitinol scoring element with 4 rings and 12 rectangular wires/struts 12 French sheath compatible (0.035” guidewire) RBP 5-8 atm with scoring element force amplification ~18x Rapid deflation time <5 seconds

Valvuloplasty Scoring Balloon Deflated Inflated

Inflation – Deflation

Device Positioned Across Aortic Valve Porcine Study Device in Descending Thoracic Aorta tip marker - yellow arrow, balloon/scoring element markers - white arrows Device Positioned Across Aortic Valve

Ovine Study Device Inflated in Aortic Valve Device Deflated with Scoring Element Re-Wrap

Deflated Device in Aortic Valve Device Inflated in Aortic Valve ICE During Deployment Deflated Device in Aortic Valve Device Inflated in Aortic Valve

Acute Necropsy Results

Pre-Clinical Testing & Future Plans Qualitative effects in cadaveric AS ✓ Bench testing/optimization ✓ Porcine deliverability study completed ✓ Ovine safety & deliverability study completed ✓ FIM study planned to start 1Q2012

FIM Study Design Phase I (~5 pts) Phase II (~30 pts) - Intra-operative evaluation immediately prior to SAVR - Direct inspection, qualitative assessment - TEE pre and post-intervention - If no safety concerns proceed with Phase II Phase II (~30 pts) - High risk pts with degenerative/calcific AS referred for BAV - Percutaneous valvuloplasty with scoring balloon - Pre and post-procedure hemodynamics, TTE - Clinical f/u and TTE at 30 days, 6 and 12 months