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|CryoLife, Inc. Receives CE Mark Approval For Synergraft(R) Tissue-Engineered Vascular Graft For Dialysis Access And Peripheral Vascular Reconstruction|
|ATLANTA, Aug 23, 2001 /PRNewswire/ --|
New Graft Has the Potential to Repopulate Itself With the Recipient's Own CellsCryoLife, Inc. (NYSE: CRY), a life- science company involved in the development and commercialization of cryopreserved and tissue-engineered implantable heart valves, vascular and orthopedic reconstruction grafts, and surgical adhesives, today announced that it has received a CE (product certification) Mark allowing the commercial distribution of its SynerGraft Model 100 tissue-engineered vascular graft within the European Community.
The new vascular graft was developed using the Company's patented SynerGraft technology, which centers around the removal of antigens from human and/or animal tissue leaving a collagen matrix that has the potential to be repopulated with the patient's own cells. The SynerGraft vascular graft was created by removing the cells from bovine tissue, providing for a sterile, implantable, collagen matrix capable of being repopulated with the recipient's own cells.
The SynerGraft vascular graft is directed toward patients who have experienced negative reactions from synthetic vascular grafts and as a result require replacement vascular grafts that reduce the risk of infection and provide for long-term functionality. CryoLife's A-V access graft addresses a European population of over 200,000 dialysis patients.
Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc., said, "The SynerGraft vascular graft represents the latest addition to the Company's family of SynerGraft tissue-engineered implantable devices that are providing new alternative treatments for patients who have compromised vascular function and who would benefit from a vascular replacement that has the potential to be remodeled with the recipient's own cells."
The SynerGraft technology has been successfully used in the development of aortic and pulmonary replacement heart valves that were awarded CE (product certification) Marks in 2000. Both SynerGraft tissue engineered heart valves are currently commercially available within the European community.
Founded in 1984, CryoLife, Inc., is the leader in the development and commercialization of implantable living human tissues for use in cardiovascular, vascular and orthopedic surgeries throughout the United States and Canada. The Company's BioGlue(R) surgical adhesive is approved as an adjunct for acute thoracic aortic dissections under HDE regulations in the United States and is CE marked in the European Community and approved in Canada and Australia for use in vascular and pulmonary sealing and repair. The Company also manufactures the SynerGraft(R) heart valve, the world's first tissue-engineered heart valve replacement and the CryoLife-O'Brien(R) and CryoLife-Ross(R) stentless porcine heart valves, which are CE marked for distribution within the European Community. The human heart valves and vascular grafts processed by CryoLife using the SynerGraft technology are distributed in the U.S. under the trade names of CryoValve(R)SG and CryoVein(R)SG, respectively.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes regarding future occurrences are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These future events may not occur when expected, if at all, and are subject to various risks and uncertainties. Such risks and uncertainties include the possibility that SynerGraft-treated tissues will not have the expected long-term functionality, repopulate with human recipient cells, reduce immune response, or remain infection free, that future clinical SynerGraft test results will prove less encouraging than current results, that SynerGraft regulatory submissions will not be ready when planned or that anticipated regulatory approvals will not be obtained on a timely basis, if at all, and other risk factors detailed in the Company's Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended December 31, 2000.
For additional information about the company, visit CryoLife's web site: http://www.cryolife.com .
Contact: Roy Vogeltanz Vice President, Corporate Communications (800) 438-8285SOURCE CryoLife, Inc.
CONTACT: Roy Vogeltanz, Vice President, Corporate Communications of CryoLife, Inc., +1-800-438-8285