GAITHERSBURG, Md. (Reuters) – An artificial aortic valve from Edwards Lifesciences Corp that can be inserted without opening the chest for surgery won the support of U.S. advisers on Wednesday for use in a wider group of patients.
The device is already approved for patients with aortic stenosis who are ineligible for surgery.
Today a panel of outside advisers to the U.S. Food and Drug Administration voted unanimously, with one abstention, that the benefits of the Sapien device outweigh its risks for people who need a new heart valve but are high-risk surgical patients.
The FDA usually follows panel recommendations, although it is not required to, and will make a final decision later.
With an Edwards’ Sapien transcatheter heart valve — the first such device in the United States — a catheter guides the new valve to the heart through the femoral artery in the groin or a small incision between the ribs. The valve costs about $30,000 and is made of cow tissue and polyester supported with a stainless steel mesh frame.
In pivotal clinical trials, Edwards said the Sapien led to a slightly lower death rate and dramatically shorter recovery times and hospital stays than open-heart surgery.
However, FDA advisers were also concerned about higher stroke risk with the device compared to the traditional surgery, as well as about aortic leakage.
“I think we are in belief that the totality of the data demonstrate a reasonable assurance of safety and efficacy,” said Dr. Warren Laskey, the panel chair and a cardiologist at the University of New Mexico School of Medicine.
“There are questions that remain unaddressed, but they don’t seem to impede our acceptance of the totality of the data.”