CryoLife pulmonary SynerGraft valve

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Jennie

Well-known member
Joined
Jun 11, 2001
Messages
258
Location
near Washington, DC
Hey Jennie,

Thanks for the new info! It sounds like you are doing well with your aortic SG after 6 years. Good for you! Your success shows us that everyone and every situation is different. Thanks for sharing this.

John
 
Yes, actually, I have had quite a few phone discussions with John both before and after his surgeries and his terrible ordeal. And yes, CryoLife did voluntarily pull the SG valves from the market about four months after I received mine, after which I had a little email discussion with my surgeon, who continued to support this valve in hopes that it would come back on the market.

The FDA was concerned because the valves were not sterilized, BUT, one cannot sterilize human tissue in the traditional sense without compromising its integrity. So the problem was that, in a few cases, none (that I am aware) of which were valves (it was knee cartilage, etc), a fungus of some sort was transfered from the donor to the recipient, resulting in bad news. So CryoLife pulled everything off the shelves. Keep in mind that CryoLife continues to be one of the leading providers of biomaterials for tissue implantation, not just for the SG valves but also for traditional non-SG valves and a host of other materials.

And with John, it's not for me to say, but I agree with John (Lionheart) here, everyone is different. His overall experience with heart valve surgery was not very positive from the start, and whether he got a bum valve or whether there were other factors in his situation that came into play, or perhaps a combination of both, leaves all of us a bit nervous.

So, certainly, thank you for the concerns here, and anyone considering the SG should certainly have a few questions to ask their surgeons. But I do hope we don't throw the baby out with the bathwater. Personally, I thank God for my SG, and if I ever need one again, I sure hope they are available!
 
Hi Oaktree,

Interesting point! I will have to look up that book. I hadn't really given the collection process much thought with respect to myself and my valve. Hopefully this issue will continue to be brought to light, and ultimately be brought under some sort of federal regulation (if not already) to ensure the products on the market are high-quality and safe. It was scary to hear that the SGs were pulled, when I had just received one, and scary to discuss John's situation with him. But I am glad that the FDA stuck its nose in, if only to keep the industry vigilant in these matters. And it reminds me that even while technology has advanced to provide us with so many exciting choices, this type of surgery is still not without risk....
 
Cryolife did have other issues with the FDA as well. While the recall was voluntary, the production shutdown was not, and it was not just those valves that they were enjoined from producing.

They also had some spectacular failures with the valves prior to that, especially with very young children, for whom it was thought these could be a godsend.

I was heavily interested in what they had to offer, because it held the hope of being a truly permanent valve. If they get it all figured out, that hope is still there.

The pulmonary valve could be the answer that folks with the Ross Procedure have always been seeking.


Best wishes,
 

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