1. 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

2. 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
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3. 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)

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

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

6. 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

7. 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

8. Valvuloplasty Scoring Balloon
Deflated
Inflated

9. Inflation – Deflation

10. 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

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

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

13. Acute Necropsy Results

14. 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

15. 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