A panel of expert cardiologists has endorsed Edwards Lifesciences’ Sapien transcatheter heart valve and recommended the US Food and Drug Administration (FDA) approve it for the treatment of certain inoperable patients with severe aortic stenosis. The panel also urged the FDA require that a managed register is set up of patients fitted with the device.

The FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 9 to 0 with one abstention, that the benefits of the aortic heart valve, which is inserted through an artery without the need for open heart surgery, outweigh the risks for patients who are too frail to have conventional valve replacement surgery, reports the Associated Press.

The panel, which met in Gaithersburg, Maryland on Wednesday, voted that the procedure was safe (7-3 in favor), and effective (9-1 in favor), according a report from Forbes’ CardioBrief, which also suggests that the panel was concerned the device might be used in patients who did not fit the ideal profile, and by clinics that lacked sufficient experience.

One of the panel members, Rick Lange, said the committee strongly urged the FDA require that centers fitting the Sapien heart valve be on a register that logs all patients fitted with the device. The register should be supervised by the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), they said.

The panel also spent quite a bit of time looking at the risks. There appear to have been discrepancies, relating to the PARTNER B trial data, between what the company thought the risks were and what the FDA analysts, who reviewed the trial data and submitted their report to the committee a few days earlier, thought they were. The FDA reviewers had expressed concerns about safety of the Sapien heart valve, saying it put patients at higher risk for stroke and other neurological effects.

Edwards submitted their premarket approval (PMA) in the fall of 2010, based on data from the inoperable cohort of the PARTNER trial where 358 patients with severe aortic stenosis underwent treatment either with standard valve replacement therapy or the Sapien transcatheter heart valve.

Aortic stenosis is where the valve to the aorta, the main artery that carries blood from the heart, is faulty. About 300,000 people in the US have this condition, according to Edwards Lifesciences.

The main advantage of the Sapien valve is that it can be inserted without the need for open-heart surgery: the surgeon inserts it either via the femoral artery through a small cut in the patient’s groin, or through an incision between the patient’s ribs into the left ventricle of the heart.

Edwards Lifesciences’ chairman and CEO, Michael A. Mussallem, said in a statement that they wished to thank the panel for “their comprehensive and thoughtful review”, and also all the participants for taking part in the trial, and the investigators and heart teams at the PARTNER hospitals for their dedication.

The Sapien valve received its CE Mark approval for the European market in 2007.

The FDA does not have to follow the recommendations of its Advisory Committees, but it usually does.

If it gets FDA approval, the Sapien device would be the first transcatheter valve to be sold in the US, where the market is estimated to reach $1.3 billion by 2014, according to a report from Bloomberg Industries.

Sources: FDA, marketwire (press release), Forbes (CardioBrief), Associated Press, Bloomberg.

Written by: Catharine Paddock, PhD