I saw this in the news today....
FDA Okays Stripped-Down Version of Human Heart Valve
ROCKVILLE, Md., Feb. 8 -- The FDA has approved the first prosthetic heart valve made from decellularized human tissue as a replacement for a diseased or damaged pulmonary valve.
The CryoValve SynerGraft pulmonary valve is manufactured from cadaver tissue that is stripped of both cells and cellular debris, which leaves a functioning scaffold of connective tissue that is less likely to trigger an immune response and/or tissue rejection.
The SynerGraft valve was approved for use in patients who require replacement of their pulmonary valve because of disease, malformation, or malfunction of native pulmonary valves, or as part of another surgical procedure.
The FDA approved the device based on data that compared 342 SynerGraft valves implanted over a four-year period from 2000 to 2004 with 1,246 traditional allograft valves implanted during the same period.
Comparing the endpoints of mortality, device-related re-operations, endocarditis, and thrombus formation, the SynerGraft valves performed as well as the traditional valves -- a noninferiority measure required for marketing approval.
The SynerGraft valve is made by CryoLife of Kennesaw, Ga.
Article copied from MedPageToday
FDA Okays Stripped-Down Version of Human Heart Valve
ROCKVILLE, Md., Feb. 8 -- The FDA has approved the first prosthetic heart valve made from decellularized human tissue as a replacement for a diseased or damaged pulmonary valve.
The CryoValve SynerGraft pulmonary valve is manufactured from cadaver tissue that is stripped of both cells and cellular debris, which leaves a functioning scaffold of connective tissue that is less likely to trigger an immune response and/or tissue rejection.
The SynerGraft valve was approved for use in patients who require replacement of their pulmonary valve because of disease, malformation, or malfunction of native pulmonary valves, or as part of another surgical procedure.
The FDA approved the device based on data that compared 342 SynerGraft valves implanted over a four-year period from 2000 to 2004 with 1,246 traditional allograft valves implanted during the same period.
Comparing the endpoints of mortality, device-related re-operations, endocarditis, and thrombus formation, the SynerGraft valves performed as well as the traditional valves -- a noninferiority measure required for marketing approval.
The SynerGraft valve is made by CryoLife of Kennesaw, Ga.
Article copied from MedPageToday
