U.S. FDA Approves LivaNova’s Perceval Sutureless Aortic Heart Valve

LivaNova, formed from the merger of Sorin and Cyberonics, has received FDA approval for its Perceval sutureless aortic heart valve to the U.S. market. The firm will begin commercial distribution of the device in the U.S. over the coming quarter.

The company in a press release revealed that Perceval is a surgical aortic valve with a unique self-anchoring frame that allows the surgeon to replace the diseased valve without suturing it into place.

The Perceval’s functional component is made of bovine pericardium and is mounted on a super-elastic alloy frame. Clinical results have shown a notable reduction in surgical procedural time for both complex and isolated aortic valve replacement with aortic cross-clamp times typically reduced by at least 50 percent.

An aortic cross-clamp is a surgical device used in the surgery to clamp the aorta and separate the systemic circulation from the outflow of the heart.

“We are excited to bring this important product to the U.S. market, which will provide real value to patients and physicians. The rapid acceptance of Perceval in Europe, an increasing number of positive publications on the product, and the solid preparation of our U.S. sales team, all provide a strong base for the achievement of our short and long term plans,” said Andre-Michel Ballester, Chief Executive Officer.

Source-Medindia