Approval expanded for sapien artificial heart valve

(HealthDay)—U.S. Food and Drug Administration approval for the Sapien Transcatheter Heart Valve has been expanded to include additional people with aortic valve stenosis, the medical term for a narrowing of the aortic valve that prevents the valve from functioning properly.

The new approval sanctions the artificial valve for patients who are at above-average risk of complications from valve surgery, including the possibility of death, the agency said Friday in a news release. The valve was first approved in 2011.

The device is implanted without opening the chest. It is compressed and placed into a delivery that's inserted through an artery in the leg and is threaded to the site of the diseased valve.

The replacement valve should not be implanted in people who cannot tolerate anti-clotting therapies, the FDA warned.

Device maker Edwards Lifesciences Corp, based in Irvine, Calif., will conduct ongoing studies to monitor the valve's performance among recipients, the agency said.

More information: To learn more about this condition, visit the American Heart Association.

add to favorites email to friend print save as pdf

Related Stories

FDA favors innovative heart valve for the frail

Jul 18, 2011

The first artificial heart valve designed to be implanted without major surgery appears to help patients who are too frail to undergo chest-opening surgery, according to federal health reviewers.

FDA approves innovative, non-invasive heart valve

Nov 02, 2011

(AP) -- Federal health officials have approved a first-of-a-kind artificial heart valve that can be implanted without major surgery, offering a new treatment option for patients who are too old or frail for the chest-cracking ...

US reviews safety of innovative heart valve (Update 2)

Jun 11, 2012

(AP) — U.S. health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery, ahead of a meeting this week to consider broadening its use.

Heart valves implanted without open-heart surgery

Jan 07, 2009

An innovative approach for implanting a new aortic heart valve without open-heart surgery is being offered to patients at NewYork-Presbyterian Hospital/Columbia University Medical Center. Known as the PARTNER (Placement of ...

Recommended for you

Use of drug-eluting stents may cut in-hospital mortality

Nov 20, 2014

(HealthDay)—Use of drug-eluting stents (DES) rather than bare-metal stents (BMS) for percutaneous coronary intervention (PCI) is associated with lower rates of in-hospital mortality, according to research ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.