Rick W asked me in a private messate about the FDA approval of the CryoLife Synergraft valves, and I though it might be helpful to this discussion if I posted my response to him here as well.
Here it is:
Hi Rick,
Yes, it was and is FDA approved, as far as I know and I've been following the situation fairly well. However, the FDA temporarily suspended some of its tissue production last year because of contamination problems. That was not specific to the SynerGraft, but to many of CryoLife's tissue products.
My experience with it has been mixed.
The new valve is leaking some and should not be at all, or at least not anywhere near as much as it is for me. I regularly have edema around my ankles and am on medication (Diovan and aspirin), with occasional flutterings, none of which symptoms I should be experiencing with a new valve. Obviously, something is defective with the particular valve that I got.
On the other hand, my body seems to have been able to remodel it enough to stabilize it at an endurable level, and that might not have been possible if it were not a SynerGraft valve. Who knows!? If I endure at this level without degradation, that will be a plus for the SynerGraft, and if not, well then, back to the cutting board!
I think the first issue in valve choice is between a mechanical and a tissue valve, and that is mostly a trade-off between a lifetime of anti-coagulation drugs or more surgery down the road. I think you should first be comfortable with the decision of an ordinary homograft over a mechanical valve before you consider the SynerGraft, which it was in my case.
Then, if you are willing to take the chance, you should consider the choice between an ordinary homograft and a SynerGraft treated valve.
Best of luck and Godspeed with you choice and your surgery. I will try to stay tuned on vr.com for updates and please feel free to contact me at any time for further input.
Steve
Rick W wrote on 04-10-2003 02:21 PM:
Hi Srwieland.
Do you know then, if the Synergraft is in fact FDA approved? I was under the impression it already was. It sounds like it is working well for you. You and I are almost the same age which helps for comparision. I am getting my Angiogram done next week so I know that a valve selection choice will follow soon.
Thanks for any input you may have.
Rick