CryoLife, Inc. Announces New Tissue-Engineered Vascular Graft for Dialysis Patients
ATLANTA, Jan. 17 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), the leader in the development and commercialization of living tissue implantable devices and a manufacturer and distributor of stentless heart valves and surgical adhesives, today announced that it had expanded its human vascular graft program to include a new method of preserving vascular tissue used as an A-V (arteriovenous) access graft for application with dialysis patients.
The new vascular graft, called CryoVein(R) SG, incorporates CryoLife's patented SynerGraft(R) technology into preserved human vascular grafts. The SynerGraft technology depopulates the native cells of the donor femoral vein providing a collagen matrix that has the potential to repopulate itself with the patient's own cells, possibly eliminating the risk of tissue rejection and reducing the risk of infection in implanted patients.
The new CryoVein SG is directed toward patients who have experienced negative reactions to synthetic or tissue A-V access grafts and require replacement grafts that reduce risk of infection and provide for long-term functionality.
On January 9, 2001, the first CryoVein SG was implanted in a fifty-one-year-old female dialysis patient at the Baystate Medical Center, Springfield, Massachusetts, by Dr. George Lipkowitz, Director of Transplantation, and Dr. Alex Kurbanov. A second patient, a seventy-nine-year-old male, received a CryoVein SG vein graft as his primary A-V access graft on January 16, 2001. Both patients had their CryoVein SG grafts done as an "outpatient" procedure. The primary indication for the first CryoVein SG implant was repeated thrombosis of the patient's synthetic graft. In the U.S. there are approximately 300,000 people currently on dialysis and an additional 10 percent being added each year. Of the 300,000 about 50,000 are on the kidney transplant waiting list. For dialysis patients it is essential to maintain appropriate A-V access for effective treatment.
Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc., said, "The CryoVein SG is the latest addition to CryoLife's family of tissue-engineered implantable devices that use the Company's SynerGraft technology. SynerGraft A-V access devices have the potential to repopulate themselves with the patient's own cells providing a lifetime implantable device that functions similarly to the patient's own tissue."
Founded in 1984, CryoLife, Inc. is the leader in the development and commercialization of implantable living human tissues for use in cardiovascular, vascular and orthopaedic 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 Union and approved in Canada 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 distributed within the European Community. The Company's SynerGraft processed human heart valves and vascular grafts are marketed under the trade names of CryoValve(R) SG and CryoVein SG, respectively.
Statements made in this 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 CryoVein SG will not repopulate with human recipient cells, or if repopulation does occur, that it will not have the anticipated effects, 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, that the CryoVein SG will not be accepted by surgeons 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, 1999.
Thrombosis -- The obstruction of a blood vessel by a clot formed at the site of obstruction
For additional information about the company, visit CryoLife's web site, http://www.cryolife.com
| Contact: | Roy Vogeltanz |
|---|---|
| Vice President, Corporate Communications | |
| (800) 438-8285 |
SOURCE CryoLife, Inc.
CONTACT: Roy Vogeltanz, Vice President of Corporate Communications of CryoLife, 800-438-8285/
