Optimum TAV’s design mimics that of the natural aortic valve, resulting in an efficient structure with a reduced-stress configuration and prolonged durability.
Optimum TAV is a low profile, self-expanding valve, composed of a nickel-titanium (nitinol) frame and bovine pericardial tissue leaflets. Optimum TAV is delivered through the Company’s multi-access catheter.
Differentiating Features Include:
- Optimized leaflet design, resulting in proper opening and coaptation
- Low profile, self-expanding
- Large Effective Orifice Area
- No wrinkles in the leaflets, best leaflet dynamics
- No needle holes in the flexing part of the leaflets
- In a durability tester, the valve continues to function beyond 880 million cycles (simulating 24 years in vivo).
- High skirt to prevent paravalvular leaks
- Stronger frame to treat Bicuspid valve patients
- Designed for valve-in-valve implantation (TAV-in-SAV as well as TAV-in-TAV)
Avoids the Following Design Limitations:
- Multiple suture lines (potential leaflet wear)
- Balloon expansion (potential tissue damage)
- Blood flow through a wire mesh (potential thrombo-embolism)
- Contact between the leaflets and native valve (potential leaflet wear)
“Designed for Durability”
Optimum TAV mimics the natural aortic valve’s geometry** and satisfies the following “4 Design Criteria for Optimum Performance” discovered by Dr. Thubrikar:
- A specific coaptation height (to prevent leaks)
- No folds in the leaflets (to eliminate stresses due to folding)
- Minimum overall height (to reduce dead space)
- Minimum leaflet flexion (to reduce flexion stresses)
Optimum TAV – constructed for maximum durability and hemodynamic performance – is “Nature’s Valve by Design.”
Optimum TAV is an investigational device and not available for commercial sale in the U.S. or any other region.