FDA okays heart valve implanted without open-heart surgery

Implanted through a cut in the leg, the Sapien Transcatheter Heart Valve is now an option for patients ineligible for open-heart surgery. It's made of cow tissue, polyester, and stainless steel mesh.
Written by Janet Fang, Contributor

This week, the US Food and Drug Administration approved the first artificial heart valve that can replace a damaged aortic heart valve without open-heart surgery.

While the patients in a clinical trial who received the Sapien Transcatheter Heart Valve experienced more strokes and complications, they were also more likely to survive one year afterwards.

The aortic valve lies between the aorta, the largest artery in our body, and the left ventricle, one of the 4 chambers of the heart.

The valve can become damaged by senile aortic valve stenosis – a progressive, age-related disease caused by calcium deposits on the valve. Since the heart works harder to pump blood through the narrowed opening, this can lead to fainting, heart failure, and cardiac arrest.

To restore normal heart flow, patients need to replace the diseased valve with open-heart surgery, a very risky procedure for some since it involves sawing ribs open and stopping the heart.

Made of cow tissue and polyester supported by a stainless steel mesh frame, the Sapien Transcatheter Heart Valve (pictured) is now an option for patients too weak to undergo open-heart surgery.

  1. The artificial valve is compressed into the end of a long, tube-like delivery catheter, about the width of a pencil.
  2. Then it’s inserted into the femoral artery – in the thigh – through a small cut in the leg, and then it’s threaded to the site of the diseased valve.
  3. Once there, the Sapien valve is released from the catheter and expanded with a balloon (pictured). It is immediately functional.

The FDA approved the valve for patients who are ineligible for open-heart surgery. Their decision was based on a study of 365 patients:

  • Half of the patients received the Sapien valve, and they experienced 2.5 times more strokes and 8 times as many vascular and bleeding complications than those who didn’t receive the implant. BUT, they were more likely to survive one year after surgery.
  • After a year, 69% of the Sapien patients were alive compared with 50% of those who received an alternative treatment.

The Sapien valve is manufactured by Edwards Lifesciences, which has been selling such a valve in Europe since 2007. The device is expected to cost about $30,000, Reuters reports. The company expects US sales of the valve to reach as much as $25 million in the first 3 months after its debut, according to Bloomberg, and up to $250 million in its first year.

Images: Edwards Lifesciences

P.S. Happy 1 year SmartPlanet anniversary to me.

This post was originally published on Smartplanet.com

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