FDA Expands Approval for 'Valve in Valve' Aortic Replacement

Share this content:
FDA Expands Approval for 'Valve in Valve' Aortic Replacement
FDA Expands Approval for 'Valve in Valve' Aortic Replacement

(HealthDay News) -- The U.S. Food and Drug Administration said Tuesday that use of the CoreValve "valve-in-valve" aortic replacement has been expanded to include people at extreme risk for serious complications from traditional open-heart surgery.

The CoreValve System is designed for people who had a prior aortic valve replacement and are now in need of a second one, the FDA said in a news release. Some people whose own valves wear out have open-heart surgery to replace the original valve with one made of animal tissue. It's when that second valve needs replacing that the CoreValve product may be prescribed.

The CoreValve valve is made of tissue from the heart of a pig. It's attached to a supportive metal frame of nickel-titanium alloy, the FDA said. Insertion is made via a catheter inserted into a leg artery, or via a small incision between the ribs. This removes the need for traditional open-heart surgery.

The valve was evaluated in a clinical trial involving 143 people. The survival rate of people who received the valve was 95.8 percent after 30 days and 89.3 percent after six months, the agency said. Major risks of the replacement valve were death, stroke, kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. The product should not be used by people with an infection, a mechanical aortic valve, among people who cannot take blood-thinning medication, and among those who have a sensitivity to titanium, nickel, or imaging contrast fluid.

The device is produced by Medtronic, based in Minneapolis.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Drug Lookup

Browse drugs by: BrandGenericDisease



Sign up for myCME e-newsletters




More in Home

Some California Mosquitoes Can Carry Zika Virus

Some California Mosquitoes Can Carry Zika Virus

Aedes aegypti mosquitoes found to transmit Zika virus

Periodontal Inflammation a Risk With Tongue Piercing

Periodontal Inflammation a Risk With Tongue Piercing

And, two young females with tongue piercings have deep lingual infrabony lesions, periodontitis

Risk of OD Highest for First Days of Opioid  Benzodiazepine Use

Risk of OD Highest for First Days of ...

Five-fold increased risk of opioid-related overdose during first 90 days of concurrent use

is free, fast, and customized just for you!




Already a member?

Sign In Now »