SynerGraft valves

[alan_delac]

SynerGraft

I was wondering if we could get an update on the success of SynerGraft valves.

SynerGraft, porcine based valves were implanted in 10 patients in Brisbane Australia and had to be taken out.

What happen to people that received homograft-SynerGraft valves? I believe some of them were doing well about 1 year after the operation. Any updates?

I exchanged a few emails with Cryolife. SynerGraft valve is under FDA review. Some believe that the review could be completed by mid to end of this year.

 

[Nancy]

A couple of years ago, there was quite a bit of discussion on these valves, mostly bad news. Try a search on Synergraft or Cryolife and maybe you can pull up some of those posts.

I thought they were a dead issue, but see they're still hanging around.

 

[tobagotwo]

As I understand it, there were issues at the time around sterility of the valves. The FDA put a halt on their operations, pending proof from the company that there were no manufacturing issues that might allow for contamination or lack of full sterilization of the valves.

This was a premium manufacturer at the time. Hopefully, they have or will have satisfied the FDA shortly.

Best wishes,