Approval expanded for sapien artificial heart valve

October 22, 2012

(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.

Explore further: UofL physicians, Jewish Hospital first in Kentucky to offer new aortic valve replacement

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

Related Stories

UofL physicians, Jewish Hospital first in Kentucky to offer new aortic valve replacement

January 3, 2012
Some individuals with severe aortic stenosis – also known as narrowing of the aortic valve in the heart – who are not well enough to undergo open heart surgery have a new treatment option thanks to a new procedure ...

FDA favors innovative heart valve for the frail

July 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

November 2, 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)

June 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.

Recommended for you

Early study shows shoe attachment can help stroke patients improve their gait

December 14, 2017
A new device created at the University of South Florida – and including a cross-disciplinary team of experts from USF engineering, physical therapy and neurology – is showing early promise for helping correct the signature ...

Scientists rewrite our understanding of how arteries mend

December 13, 2017
Scientists from The University of Manchester have discovered how the severity of trauma to arterial blood vessels governs how the body repairs itself.

Deadly heart rhythm halted by noninvasive radiation therapy

December 13, 2017
Radiation therapy often is used to treat cancer patients. Now, doctors at Washington University School of Medicine in St. Louis have shown that radiation therapy—aimed directly at the heart—can be used to treat patients ...

Ultra-thin tissue samples could help to understand and treat heart disease

December 12, 2017
A new method for preparing ultra-thin slices of heart tissue in the lab could help scientists to study how cells behave inside a beating heart.

Young diabetics could have seven times higher risk for sudden cardiac death

December 12, 2017
Young diabetics could have seven times more risk of dying from sudden cardiac arrest than their peers who don't have diabetes, according to new research.

Research reveals how diabetes in pregnancy affects baby's heart

December 12, 2017
Researchers at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have discovered how high glucose levels—whether caused by diabetes or other factors—keep heart cells from maturing ...

0 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.