Cryolife's BioGlue Surgical Adhesive Featured At 36th Annual Meeting of the Society of Thoracic Surgeons.Business &Health/Medical Editors 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 NYSE See: New York Stock Exchange :CRY), the leader in the development and commercialization of living human tissue implantable devices and a manufacturer and distributor of stentless heart valves Heart valves Valves that regulate blood flow into and out of the heart chambers. Mentioned in: Heart Failure 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 The City of Camden is the county seat of Camden County, New Jersey in the United States. It is located just across the Delaware River from Philadelphia, Pennsylvania. As of the United States 2000 Census, the city had a total population of 79,904. , demonstrated that post-operative blood loss is significantly reduced following cardiovascular surgery cardiovascular surgery Heart surgery An operation for repairing structural defects of the cardiovascular system Examples CABG, repair of congenital heart defects, varicose veins, aortic aneurysms, ventricular remodeling, transmyocardial 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 Bleeding disorder Problems in the clotting mechanism of the blood. Mentioned in: Lithotripsy bleeding disorder Coagulopathy, see there 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, &uot;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 polymerize /po·lym·er·ize/ (pah-lim´er-iz) to subject to or to undergo polymerization. pol·y·mer·ize v. To undergo or subject to polymerization. very quickly and its strength.&uot; Steven G. Anderson, President and Chief Executive Officer of CryoLife, said, &uot;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 &uot;CE&uot; marked in Europe for vascular and pulmonary repair and has also been approved for these uses in Canada.&uot; 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 HDE Hauptverband des Deutschen Einzelhandels (Central Association of German Retail Trade) HDE Humanitarian Device Exemption HDE Heavy-Duty Engine HDE Holdrege, Nebraska (airport code) regulations in the United States and is CE marked in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community for use in vascular and pulmonary repair. The Company also manufactures CryoLife-O'Brien(R) and CryoLife-Ross(R) Stentless porcine porcine /por·cine/ (por´sin) pertaining to swine. porcine pertaining to pig. See also hog (1), swine. porcine circovirus 1 a nonpathogenic virus. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 1998. For additional information about the Company, visit CryoLife's web site: http://www.cryolife.com |
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