CryoLife Inc. (NYSE: CRY), a tissue processing and medical device company, has reached an agreement with the U.S. Food and Drug Administration that the company says permits it to immediately resume processing and limited distribution of its cardiac and vascular tissues.
The agreement allows the tissue to be released for distribution after CryoLife completes steps to assure that the tissue is used for approved purposes and that patients will be notified of risks associated with tissue use. Specifically, CryoLife must obtain physician prescriptions, and tissue packaging must contain appropriate warning labels.
The agreement also calls for CryoLife, which is based near Atlanta in Kennesaw, GA, to undertake to identify third-party records of donor tissue testing, and to destroy tissue from donors in whom micro-organisms associated with an infection are found.
In addition, the agreement, which has a 45 working-day term, specifies interim operating procedures to permit CryoLife to distribute tissues processed during the term of the agreement. CryoLife also agreed to establish a corrective action plan within 30 days with steps to validate processing procedures.
This agreement follows an order from the FDA on Aug. 13 that CryoLife recall distributed human tissue processed from Oct. 3, 2001, to August 2002. Under the order, the company also has to withhold from the market or destroy tissue processed after that date. The FDA said it took those actions because it determined CryoLife cannot ensure that the human tissue it processes for transplantation is free from fungal and bacterial contaminants. Tissue from a donor processed by CryoLife on and after Oct. 3, 2001, has been associated with the death of a patient on Nov. 7, 2001, who received a soft tissue implant during reconstructive knee surgery.
Since 1984, more than 90,000 CryoLife preserved allograft tissues have been implanted. The overall infection rates in surgeries involving CryoLife tissues are comparable to or below published infection rates in surgeries involving sterile synthetic implant devices.