For Immediate Release
June 17, 2015
The U.S. Food and Drug Administration today approved the SAPIEN 3 Transcatheter Heart Valve (THV) for patients with a narrowing in the heart's aortic valve, called aortic valve stenosis. Aortic valve stenosis obstructs blood flow from the heart into the aorta, which can lead to serious heart problems. The SAPIEN 3 THV is approved for patients with aortic valve stenosis who are inoperable or at high risk for death or complications associated with open-heart surgery.
The SAPIEN 3 THV is the third generation of the SAPIEN THV that FDA originally approved in 2011. The device has a major design change that adds a skirt at the base of the valve to minimize leakage around the valve.
Calcium deposits can form on the aortic valve due to aging. These calcium deposits may never cause any problems; however, in some patients, they are one of the causes of aortic valve stenosis. As the aortic valve becomes narrow, the heart has to work harder to pump enough blood through the smaller opening, and the heart may weaken as a result. Aortic valve stenosis can cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest. Patients with severe aortic valve stenosis generally need to have a heart valve replacement to improve blood flow through their aortic valve.
“Clinical data showed that the SAPIEN 3 Transcatheter Heart Valve is superior to the first generation SAPIEN Transcatheter Heart Valve, with significantly less leakage through and around the valve,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health.
The SAPIEN 3 THV can help correct the blood flow problem associated with aortic stenosis in patients who need open-heart surgery to replace the diseased valve, but for whom the surgical procedure is deemed by their doctors to be highly risky or too risky. Because of the overall risks and extended recovery time associated with open-heart surgery, about 30 percent of patients are considered inoperable or at high risk for surgical complications and are not referred for open heart surgery. In the clinical studies, the SAPIEN 3 THV demonstrated a reasonable assurance of safety and effectiveness for those patients without the need for open-heart surgery.
Patients who receive the SAPIEN 3 THV, however, also face a risk of serious complications from the implantation procedure, such as death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker.
The device is contraindicated (should not be used) for patients who cannot tolerate anticoagulation/antiplatelet therapy.
FDA based approval of the SAPIEN 3 THV on a clinical study involving 583 patients with aortic valve stenosis who were at high risk for open heart surgery or who could not undergo the surgery due to excess risk.
The rate of moderate or greater aortic insufficiency (leakage through and around the valve) at 30 days was significantly lower following valve implantation in patients treated with the SAPIEN 3 THV (3.0 percent on average) when compared to the rate seen in patients treated with the SAPIEN THV (14.3 percent on average).
The Sapien 3 THV is manufactured by Edwards Lifesciences, LLC, based in Irvine, California.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.