FDA Approves Artificial Heart Valve

The FDA has approved an artificial heart valve designed to minimize leakage.

The Sapien 3 Transcatheter Heart Valve (THV) can be used to treat patients with aortic valve stenosis, which disrupts blood flow from the heart into the aorta. The FDA approved the Sapien 3 THV for patients who are inoperable, at high risk for death, or who face complications associated with open-heart surgery.

The first design of the product was approved in 2011; this third generation of the Sapien THV involves a skirt at the base of the valve, which is intended to minimize leakage around the valve.

“Clinical data showed that the Sapien 3 THV is superior to the first generation Sapien THV, with significantly less leakage through and around the valve,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health, said in a press release.

A clinical study of the valve involved 583 patients with aortic valve stenosis, who were at high risk for open heart surgery or who could not have surgery due to excess risk. The results of the study showed that after 30 days, patients saw less leakage around the valve when treated with the Sapien 3 THV (3% on average) compared with those treated with the Sapien THV (around 14% on average).

While the valve can help with problems associated with aortic stenosis, there is a chance of serious complications from the implantation procedure, such as death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker.

Patients who cannot tolerate anticoagulation or antiplatelet therapy should not be treated with the Sapien 3 THV.