LivaNova, formed from the merger of Sorin and Cyberonics, won FDA approval to introduce its Perceval sutureless aortic heart valve to the U.S. market. The valve features a placement system that does not require suturing, which may substantially reduce procedure times over other valves.
Like many other replacement valves, the flapping leaflets of the Perceval are made of bovine pericardium. These are mounted over a flexible metal alloy frame that conforms to the heart’s natural motion.
Some features according to the product page:
- The reduced collapsed profile prevents trauma to the aortic wall enabling a full and direct view.
- The temporary guiding sutures the valve by guiding it along the annulus axis even in narrow spaces.
Ease of implant:
- Traditional valves require from 15 to 18 permanent sutures. Perceval is a truly sutureless valve.
Optimal stress absorption
- The elastic structure aims at reproducing the stress absorption properties of the native tissue at the valve commissures level
The Perceval valve passed a test 3 times harder than what is required by the I.S.O. and F.D.A. guidance (no failure after 600 million cycles)
- This Perceval valve showed no failure after 2 Billion cycles, equivalent to 50-year heart cycles in-vivo.
Product page: Perceval…