The U.S. Food and Drug Administration approved Thursday the SAPIEN 3 Transcatheter Heart Valve meant for treating patients with aortic valve stenosis, a narrowing in the aortic valve of the heart.

Aortic valve stenosis prevents blood from flowing freely from the heart and into the aorta, leading to serious heart problems. The SAPIEN 3 THV helps in addressing the condition in patients that cannot get surgical treatment because of high risks. Now the third iteration of the device first approved by the FDA, the SAPIEN 3 THV has been improved to add a skirt around the valve's base to minimize leakage.

As the aortic valve narrows (due to a number of reasons, one of which is calcium deposits), the heart labors to ensure enough blood is pumped through the smaller opening, resulting in a weakened heart. Aortic valve stenosis causes chest pains, fainting, heart failure, cardiac arrest or irregular heart beats. In severe cases, a heart valve replacement is needed to improve the flow of blood.

According to William Maisel M.D., M.P.H., Office of Device Evaluation acting director from the Center for Devices and Radiological Health at the FDA, the SAPIEN 3 showed superiority over the first generation model of the THV.

"We believe the SAPIEN 3 valve has the potential to transform patient care in the U.S.," added Larry L. Wood, corporate vice president for transcatheter heart valves at Edwards Lifesciences.

SAPIEN and SAPIEN 3 THV are manufactured by California-based Edwards Lifesciences. SAPIEN was originally approved in 2011 while SAPIEN 3 was made available in Europe last year. The SAPIEN family has collectively treated over 100,000 patients around the world.

Due to general risks and the extended recovery period that open-heart surgery requires, not all patients suffering from aortic valve stenosis can turn to surgical treatment, no matter how severe their condition may be. SAPIEN 3 THV can help them by correcting the problem in the heart's blood flow, with effectiveness and safety proven in clinical studies although there remains the risk for acute kidney injury, bleeding, heart attack, stroke and death arising due to the implantation procedure.

The FDA approval for the SAPIEN 3 THV is based on a clinical study with 583 aortic valve stenosis patients. The rate of moderate to greater aortic insufficiency at one month was dramatically lower in patients after implantation compared to those who were treated with the original SAPIEN THV.

Photo: Garrett Ammon | Flickr

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