LivaNova PLC announced that, on January 8, 2016, the company received approval from the United States Food and Drug Administration for the Perceval Sutureless Heart Valve. The approval is effective immediately, and the company will begin commercial distribution of the device in the U.S. over the coming quarter. Perceval is a surgical aortic valve with a unique self-anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place.

The valve's functional component is made of bovine pericardium and is mounted on a super-elastic alloy frame. Clinical results in patients implanted with Perceval have shown a significant reduction in surgical procedural time for both isolated and complex aortic valve replacement with aortic cross-clamp times typically reduced by at least 50%. Perceval is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

The sale and distribution of the Perceval heart valve is limited to prescription use by specially-trained practitioners, and the company has developed a nationwide training and proctoring program to help ensure the safety and effectiveness of the device.