Cryolife Gets FDA Approval For Decellularized Tissue Heart Valve Replacement
February 12th, 2008Interesting new technical break-through for tissue heart valve replacements!
On February 7, 2008, the U.S. Food and Drug Administration cleared for marketing the first replacement heart valve from donated human tissue in which the cells have been removed, according to Medical News Today.
Traditionally, when human tissue is recovered from a cadaver for future implantation, it is inspected, cleaned and decontaminated to prevent infection, but the allograft product remains otherwise unchanged. CryoLife has added a manufacturing step to its CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft (SynerGraft) that decellularizes or 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.
“Today’s clearance is a promising advance in allograft products,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “FDA welcomes innovations in manufacturing that provide more medical options for patients.”
To learn more, see Cryolife’s press release regarding its decelluarlized heart valve replacement.
Hopefully this is another step in the right direction for Cryolife following their FDA valve replacement recalls in 2002.
Keep on tickin!
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| About The Author: Adam Pick is a double, heart valve surgery patient and author of The Patient's Guide To Heart Valve Surgery. This unique book integrates clinical research with the personal experiences of 135 former patients to help future patients and their caregivers better understand the problems, the opportunities and the realities of heart valve surgery. To learn more about Adam and his heart valve surgery book, click here. |
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