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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:

1. 1. A specific coaptation height (to prevent leaks)
   2. No folds in the leaflets (to eliminate stresses due to folding)
   3. Minimum overall height (to reduce dead space)
   4. Minimum leaflet flexion (to reduce flexion stresses)

 

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Optimum TAV is an investigational device and not available for commercial sale in the U.S. or any other region.