FDA News

Sutureless valve for surgical aortic valve replacement receives FDA approval

LivaNova PLC announced that the FDA has approved its sutureless heart valve for use in surgical aortic valve replacement.

The valve (Perceval, LivaNova PLC) is made from bovine pericardium and has a self-anchoring frame that allows a surgeon to replace a diseased aortic valve without suturing the replacement valve into place, according to a company press release. It is indicated for replacement of diseased, damaged or malfunctioning aortic valves, either native or prosthetic.

In clinical studies, implantation procedures involving the sutureless valve has led to significant reduction in surgical procedural time compared with procedures involving sutured valves, with aortic cross-clamp times often decreased by more than 50%, for patients needing isolated or complex aortic valve replacement, according to the release.

Recently, an expert consensus panel issued recommendations on the use of sutureless and rapid deployment valves.

LivaNova PLC announced that the FDA has approved its sutureless heart valve for use in surgical aortic valve replacement.

The valve (Perceval, LivaNova PLC) is made from bovine pericardium and has a self-anchoring frame that allows a surgeon to replace a diseased aortic valve without suturing the replacement valve into place, according to a company press release. It is indicated for replacement of diseased, damaged or malfunctioning aortic valves, either native or prosthetic.

In clinical studies, implantation procedures involving the sutureless valve has led to significant reduction in surgical procedural time compared with procedures involving sutured valves, with aortic cross-clamp times often decreased by more than 50%, for patients needing isolated or complex aortic valve replacement, according to the release.

Recently, an expert consensus panel issued recommendations on the use of sutureless and rapid deployment valves.