In a win for LivaNova, the FDA approves the world's only sutureless aortic valve

Perceval SAVR--Courtesy of LivaNova

London's LivaNova ($LIVN) can now sell the only sutureless surgical aortic valve in the U.S., thanks to the FDA's PMA approval of its Perceval device. The company is hoping the device can overcome the strong trend toward implantation of transcatheter aortic valve replacements, which are procedurally (as opposed to surgically) installed using a delivery catheter and guidewire.

Commercial distribution of the device will commence over the coming quarter.

LivaNova, recently formed from the merger of Sorin and Cyberonics, says that by eliminating the need for sutures to secure the heart valve, the self-anchoring Perceval significantly reduces the time spent in open heart surgery. It's indicated for the "replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves," according to a release.

In a previous interview with FierceMedicalDevices, Sorin's U.S. medical director Dr. Brian Duncan pointed to an independent study of registry data from more than 2,000 European patients presented at the annual meeting of the American Association for Thoracic Surgery in Seattle. He said it showed that compared with TAVR, the Perceval had an increased rate of device success at the time of implantation using a composite measure of mortality, successful positioning and hemodynamic performance. Perceval patients had a lower 30-day mortality rate than those who received TAVR but were at higher risk of permanent pacemaker implantation.

The Perceval received CE-mark approval for use in Europe in 2011; the indication was expanded to include adults under 65 in 2014. The device got off to a slow start on the continent due to a limited manufacturing capacity at the company's Saluggia, Italy, plant, but the issue appears to have been overcome, and the company has said it expects annual revenues of the device to be €80 million to €100 million ($86 million to $108 million) over the next three to four years.

The FDA approval was based on a nonrandomized clinical trial of 658 Perceval patients in Europe who received the device between 2010 and 2013.

Perceval will compete most directly with Edwards' ($EW) CE-marked (but not FDA-approved) Intuity Elite valve, which requires only a few sutures. Medtronic ($MDT) last year pulled out of the rapid-deployment surgical aortic valve arena when it discontinued its sutureless 3F Enable after the device was tied to three patient deaths due to migration (meaning the artificial valve did not remain securely in place).

But the biggest threat to the Perceval, as with all other surgical aortic valve replacements, are TAVRs. They are expected to gain ground at the expense of traditional surgical valves once they gain "intermediate risk" indication perhaps toward the end of this year, at least in the case of Edwards' Sapien franchise. In fact, that company has said it anticipates Sapien sales will eat into the sales of its surgical aortic valves to some degree.

Due to novelty of the technology and the still evolving TAVR landscape, additional studies of rapid deployment/sutureless surgical valves will play a large role in determining whether cardiologists opt for a traditional sutured valve, Perceval, Intuity or a TAVR.

A literature review in the European Journal of Cardio-Thoracic Surgery concluded that the "available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves."

- read the release
- read the PMA approval letter | here's more from the FDA (PDF)