J
John Cochran
Today Cryolife announced that it was suspending the processing of its SynerGraft heart valves.
A handful of us here have received SynerGraft valves, and no one should be worried about this news. The reason for the suspension is simply that the FDA is trying to determine whether or not the SynerGraft process should be regulated as a medical device. Neither the safety or the efficacy of the SynerGraft valves has been questioned by the FDA.
I personally feel a bit of a moral victory in this. My own AVR surgery lasted 14 hours, with 10 hours on a heart/lung machine, due to the first SynerGraft valve leaking and then, according to my surgeon, actually tearing. Fortunately, I had insisted on a second back-up SynerGraft valve, which was then implanted successfully. 8 months post-op, in spite of nearly dying during this surgery, I am doing great physically as are the other SynerGraft recipients I know.
However, I was extremely upset that the first valve appeared to have problems. The seeming lack of quality control caused me to file with the FDA what had happened to me, and my concern that the SynerGraft process appeared to be unregulated. While I continue to believe that this technology is the future, and promises huge benefits for patients, regulation and monitoring of this process is probably a good idea. I am pleased to see that our federal government, when approached correctly, responds in a reasonable and timely manner.
The relevant part of this announcement is quoted below:
"The Company has advised the FDA that it will voluntarily suspend use of the SynerGraft technology in the processing of allograft heart valves and vascular tissue until the regulatory status of the CryoValve-SG and CryoVein- SG is resolved. The FDA has not suggested that these tissues be recalled. Until such time as the issues surrounding the SG tissue are resolved, the Company will employ its traditional processing methods on these tissues. Distribution of allograft heart valves and vascular tissue processed using the Company's traditional processing protocols will continue."
The link to the full press release follows:
http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=CRY&script=410&layout=9&item_id=385623
--John
A handful of us here have received SynerGraft valves, and no one should be worried about this news. The reason for the suspension is simply that the FDA is trying to determine whether or not the SynerGraft process should be regulated as a medical device. Neither the safety or the efficacy of the SynerGraft valves has been questioned by the FDA.
I personally feel a bit of a moral victory in this. My own AVR surgery lasted 14 hours, with 10 hours on a heart/lung machine, due to the first SynerGraft valve leaking and then, according to my surgeon, actually tearing. Fortunately, I had insisted on a second back-up SynerGraft valve, which was then implanted successfully. 8 months post-op, in spite of nearly dying during this surgery, I am doing great physically as are the other SynerGraft recipients I know.
However, I was extremely upset that the first valve appeared to have problems. The seeming lack of quality control caused me to file with the FDA what had happened to me, and my concern that the SynerGraft process appeared to be unregulated. While I continue to believe that this technology is the future, and promises huge benefits for patients, regulation and monitoring of this process is probably a good idea. I am pleased to see that our federal government, when approached correctly, responds in a reasonable and timely manner.
The relevant part of this announcement is quoted below:
"The Company has advised the FDA that it will voluntarily suspend use of the SynerGraft technology in the processing of allograft heart valves and vascular tissue until the regulatory status of the CryoValve-SG and CryoVein- SG is resolved. The FDA has not suggested that these tissues be recalled. Until such time as the issues surrounding the SG tissue are resolved, the Company will employ its traditional processing methods on these tissues. Distribution of allograft heart valves and vascular tissue processed using the Company's traditional processing protocols will continue."
The link to the full press release follows:
http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=CRY&script=410&layout=9&item_id=385623
--John
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