CryoLife Inc announced that the U.S. Food and Drug Administration (FDA) has renewed its September 5, 2002, Interim Agreement with the company. The renewal allows CryoLife, a pioneer in implantable tissues and surgical adhesives, to continue processing and distributing its cardiac and vascular tissue under the terms of the original agreement for an additional 45 working days, ending January 15, 2003, or until a re-inspection is executed and an outcome determined.
As required under terms of the September 5, 2002 Interim Agreement, CryoLife submitted its corrective action plan on October 5, 2002 to the FDA and has requested an FDA re-inspection of its vascular, cardiac and orthopedic safety validation processes.
"We believe the renewal shows that CryoLife is in compliance with the Interim Agreement and on track with our progress under the corrective action plan," said CryoLife's President and CEO, Steven G. Anderson. "We continue to cooperate with the FDA and other agencies to work toward a full resolution. In the meantime, tissue remains readily available, and our procurement and distribution channels remain intact."
Terms of the Interim Agreement allow CryoLife to distribute existing and newly processed non-valved cardiac conduits and patches, saphenous veins, femoral veins and arteries, and aorto-iliac arteries for medically urgent uses when alternative treatments have been exhausted or are unavailable. Human heart valves processed by the Company and used for cardiac reconstruction were not part of the FDA Order or subject to the recall. Since 1984, more than 90,000 CryoLife preserved allograft tissues have been implanted. Management believes that CryoLife is the only tissue processing company that tracks and publishes patient outcome and tissue safety data. Collected for more than 18 years, CryoLife's data shows its tissues to be as safe or safer than synthetic implantable devices.