FDA OKs heart valve made from human tissue

Feb 07, 2008

The U.S. Food and Drug Administration has approved the first replacement heart valve made from donated human tissue in which the cells have been removed.

Traditionally, when human tissue is recovered from a cadaver for future implantation, it is inspected, cleaned and decontaminated to prevent infection, but the allograft (human) product remains otherwise unchanged.

The FDA said CryoLife Inc. has added a manufacturing step to its CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft that removes the tissue's cells and cellular debris.

What remains is a scaffold of connective tissue that still functions like a human heart valve, potentially lowering the risk of an immune response and subsequent tissue rejection, the FDA said.

Allograft heart valves are popular choices for children because they avoid the need to take blood-thinning medications on a long-term basis, officials said, and are less likely to calcify than are heart valves from a pig or cow.

The FDA said the SynerGraft valve is for use in patients who require replacement of their pulmonary valve because of disease, malformation or malfunction of their own pulmonary valve, or as part of another surgical procedure.

CryoLife is based in Kennesaw, Ga.

Copyright 2008 by United Press International

Explore further: Penis transplant offers hope to victims of botched circumcisions

Related Stories

'Map spam' puts Google in awkward place

8 hours ago

Google was re-evaluating its user-edited online map system Friday after the latest embarrassing incident—an image of an Android mascot urinating on an Apple logo.

Team develops faster, higher quality 3-D camera

8 hours ago

When Microsoft released the Kinect for Xbox in November 2010, it transformed the video game industry. The most inexpensive 3-D camera to date, the Kinect bypassed the need for joysticks and controllers by ...

Recommended for you

Game shows mosquito's-eye view of malaria

Apr 24, 2015

A new game about the life cycle of malaria that can be played on Android smartphones has been created by an Oxford University developer, based on malaria research at the University's Nuffield Department of ...

DMV program can generate additional organ donors

Apr 23, 2015

(HealthDay)—A brief, web-based training program for department of motor vehicles (DMV) employees that educates them about organ and tissue donation can increase the likelihood of customers registering as ...

User comments : 0

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.