Cryolife's BioGlue Surgical Adhesive Featured At 36th Annual Meeting of the Society of Thoracic Surgeons
ATLANTA--(BW HealthWire)--Feb. 2, 2000--
Animal Study Suggests That The Use Of
BioGlue Surgical Adhesive During Open-Heart Surgery
Can Significantly Reduce Post-Operative Blood Loss
CryoLife, Inc. (NYSE:CRY), the leader in the development and
commercialization of living human tissue implantable devices and a manufacturer and distributor of stentless heart valves and surgical adhesives, today announced that a presentation was given on February 1 at the 36th Annual Meeting of the Society of Thoracic Surgeons in Ft. Lauderdale, Florida, featuring an animal study funded by CryoLife and using CryoLife's BioGlue(R) surgical adhesive. Results of the animal study, performed by Charles W. Hewitt, PhD, Director of Surgical Research, Department of Surgery for Cooper Hospital/University Medical Center/Robert Wood Johnson Medical School in Camden, New Jersey, demonstrated that post-operative blood loss is significantly reduced following cardiovascular surgery through the use of CryoLife's BioGlue surgical adhesive versus conventional treatment of post-operative bleeding.
In the animal study, Dr. Hewitt pharmacologically created a bleeding disorder in sheep that mimicked a typical open-heart surgery bleeding problem. The sheep were then divided into two groups, with the control group receiving normal treatment for the disorder and the experimental group receiving treatment using CryoLife's BioGlue surgical adhesive. Results of the animal study demonstrated that not only was bleeding during surgery reduced in the group using BioGlue, but post-operative blood loss was also reduced by greater than 50%.
In commenting on the animal study, Dr. Hewitt stated, "We expected to see that blood loss was reduced when using BioGlue surgical adhesive, but we were pleasantly surprised to find that post-operative blood loss was reduced by more than 50%! This improved control of bleeding results from BioGlue's ability to polymerize very quickly and its strength."
Steven G. Anderson, President and Chief Executive Officer of CryoLife, said, "We are very pleased with the results of the animal study by Dr. Hewitt, particularly the reported reduction in post-operative bleeding. The use of BioGlue surgical adhesive in the United States is presently limited to the surgical repairs of acute thoracic aortic dissections pursuant to a Humanitarian Device Exemption approved by the Food and Drug Administration in December 1999. BioGlue is "CE" marked in Europe for vascular and pulmonary repair and has also been approved for these uses in Canada."
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 for use in vascular and pulmonary repair. The Company also manufactures CryoLife-O'Brien(R) and CryoLife-Ross(R) Stentless porcine heart valves which are distributed only within the European Community.
Statements made in this press release which look forward in time involve risks and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such risks and uncertainties include the possibility that future human clinical results will prove less encouraging or that BioGlue surgical adhesive will not be found to be effective in reducing bleeding in humans, changes in economic cycles, competition from other companies, changes in laws and governmental regulations applicable to the Company 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, 1998.
For additional information about the Company, visit CryoLife's web site: http://www.cryolife.com
CONTACT: CryoLife Inc.
Roy Vogeltanz, 800/438-8285
