CryoLife's BioGlue(R) Helps to Seal Vessels and Reduce Bleeding in Vascular Surgery Procedures
FDA Approves Additional BioGlue Manufacturing Facility
CryoLife, Inc. (NYSE: CRY) -- Using CryoLife's BioGlue Surgical Adhesive in conjunction with standard vessel repair methods is safe and more effective in preventing intraoperative bleeding than standard methods alone, researchers said yesterday at the American College of Surgeons 88th Annual Clinical Congress in San Francisco.On October 8, 2002, the U.S. Food and Drug Administration (FDA) approved CryoLife's PMA Supplement to manufacture BioGlue at its new expanded manufacturing facility located at the Company's Atlanta headquarters. When operational, the facility will boost the Company's ability to meet the growing demand for BioGlue.
According to a study presented by Joseph S. Coselli, MD, FACS, Baylor College of Medicine, Houston, BioGlue, a bovine serum albumin and glutaraldehyde tissue adhesive, reduces the rate of vascular anastomotic, or blood vessel repair site, bleeding in patients when used with standard repair methods, such as sutures and staples. In addition, study participants treated with BioGlue experienced a statistically significant reduction in the number of neurological complications, such as numbness or paralysis, associated with their surgery and a trend toward shorter hospitalization times.
The multi-center, randomized, controlled study entitled "Prospective Randomized Study of a Protein-Based Tissue Adhesive Used as a Hemostatic and Structural Adjunct in Cardiac and Vascular Anastomotic Repair Procedures" was conducted on 151 patients at facilities in Texas, Pennsylvania, Indiana, Florida, Georgia and California.
In December 2001, the FDA approved BioGlue in the U.S. for use in vascular anastomosis, or surgery to connect blood vessels. In Europe and other parts of the world, BioGlue is indicated for a wider variety of soft-tissue repairs, including liver, spleen, hernia, brain and lung surgeries.
"Sealing the affected vessels appropriately is key to a successful technical outcome in cardiac and vascular surgery," said T. P. Sarac, M. D., F.A.C.S., of the Cleveland Clinic, Cleveland, Ohio. "For difficult-to-sew, calcified blood vessels, and in blood vessels with weakened walls, sometimes sutures alone may not be enough, and it can be difficult to control bleeding. BioGlue augments vessel reinforcement and reduces, and possibly eliminates, the need for additional procedures to stem bleeding and the need for other hemostatic devices/agents."
The study also showed that the use of BioGlue to reinforce these blood vessel repairs reduced the need for pledgets, the felt strips commonly used with sutures to prevent the tearing of fragile tissue. BioGlue's ability to strengthen this delicate tissue also reduced the need for additional surgery to control bleeding.
About CryoLife
Founded in 1984, CryoLife, Inc. is the leader in the processing and distribution of implantable living human tissues for use in surgeries throughout the United States and Canada. The Company's BioGlue surgical adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels 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 and the SynerGraft vascular graft, the world's first tissue-engineered heart valve and vascular replacement, respectively, and the CryoLife-O'Brien(R) and CryoLife-Ross(R) stentless porcine heart valves, which are CE marked for distribution within the European Community.
About the American College of Surgeons
The American College of Surgeons, founded in 1913, is an association of surgeons dedicated to promoting the highest standards of surgical care through education of and advocacy for its Fellows and their patients. The American College of Surgeons supports programs and policies that ensure patients access to high-quality, effective care provided by appropriately prepared and well- qualified surgical specialists of their choosing.
Forward-Looking Statements. Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes regarding CryoLife's BioGlue Surgical Adhesive are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These future events may differ materially from management's expectations, may not occur when expected, if at all, and are subject to various risks and uncertainties. Such risks and uncertainties include the possibility that future clinical and research results will prove less encouraging than prior results, that the actual market for surgical sealants in cardiac and vascular surgery may prove to be smaller than anticipated or fail to grow, that BioGlue may not compete effectively with other product, and other risk factors detailed in the Company's Securities and Exchange Commission filings, including the Company's Form 10-Q filing for the quarter ended June 30, 2002.
For additional information about the company, visit CryoLife's web site: http://www.cryolife.com
CONTACT: D. Ashley Lee, Vice President & Chief Financial Officer of
CryoLife, Inc., +1-770-419-3355; or John Deaver of Fleishman
Hillard, +1-404-739-0111, for CryoLife, Inc.
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SOURCE CryoLife, Inc.
CONTACT: D. Ashley Lee, Vice President & Chief Financial Officer of
CryoLife, Inc., +1-770-419-3355; or John Deaver of Fleishman Hillard,
+1-404-739-0111, for CryoLife, Inc.
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http://www.cryolife.com
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