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CryoLife admits misstatements contained in press release about FDA warning letter.

CryoLife, Inc., Atlanta, GA announced on July 5 that it had made two misstatements in a July 24 press release saying it had received a warning letter from the US Food and Drug Administration (FDA) related to an inspection of the company's human tissue processing laboratories. (Transplant News, June 30, 2002)

The company issued the following corrections to the earlier release:

*"First, the Company confirmed that, as it had earlier noted in the Wall Street Journal, its comment to the effect that it had never received a warning letter was inaccurate, in that it had received a 1997 warning letter regarding carotid shunts manufactured by its Ideas for Medicine, Inc. subsidiary in Florida. The Company sold the product line of the Ideas for Medicine, Inc. subsidiary, consisting of disposable medical devices and infusion devices, in 1998.

*Second, with respect to the CDC's (Center for Disease Control and Prevention) investigation of two reported allograft heart valve inspections, the Company stated in its July 24, 2002 press release that it had 'received pathology data from the implanting hospitals' own laboratories that clearly demonstrated there is no infection in either valve.' Based on the pathology data it received, CryoLife believed this statement to be correct. However, in subsequent communications, a CDC representative has informed CryoLife that based on certain additional information available to the CDC, which information CryoLife has requested but not yet been able to obtain, signs of fungal infection were isolated on a culture of the explanted valve. Information currently available to the Company indicates that the valve was explanted approximately seven months after the valve was implanted."

Regarding the unusual corrections issued following the original release CryoLife President Steven Anderson said: "We are undertaking an immediate effort to obtain the reports upon which the CDC opinion is premised and fully intend to further improve our communications with hospitals, physicians, the CDC, and others in order to help insure that we receive all relevant information as soon after its release as possible."

Contact: Roy Vogeltanz - (800) 438-8285
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Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Jul 12, 2002
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