CryoLife's BioGlue(R) Surgical Adhesive Shown To Reduce Bleeding In Ventricular Assist Device Surgery
Surgical Adhesive Eliminated Need for Additional Surgery To Correct Bleeding in Study Patients
CryoLife, Inc. (NYSE: CRY), a human tissue processing and medical device company, today announced that a 21 patient study reported at the Society of Thoracic Surgeons annual meeting on February 1, 2003, indicated that CryoLife's BioGlue surgical adhesive may eliminate the need for additional surgery to correct bleeding in patients implanted with heart ventricular assist devices (VAD).According to the study, none of the patients treated with BioGlue, a bovine serum albumin and glutaraldehyde tissue adhesive, required re-operation to stop post-surgical bleeding. In contrast, 25 percent of patients not treated with BioGlue required additional surgery to correct bleeding.
The study, entitled "Clinical Utility of BioGlue Surgical Adhesive in Patients Implanted with Ventricular Assist Devices," included 21 consecutive patients and was presented by John D. Blizzard, M.D., Assistant Professor of Surgery, Oregon Health and Science University. VAD surgery is a life-saving procedure for heart failure patients awaiting a donor heart for transplant.
The study also showed that the use of BioGlue to mechanically seal the connections between the device and the patient's cardiovascular system was not related to any short- or long-term adverse event. Furthermore, the use of BioGlue did not increase the difficulty of the VAD removal and transplant procedure, according to the authors.
Dr. John Fehrenbacher of CorVasc M.D.s, Inc. of Indianapolis said, "Minimizing the possibility of re-operation for bleeding may significantly increase the patient's chance for survival until a suitable transplant heart is located."
BioGlue was approved by the U.S. Food and Drug Administration (FDA) in December 2001 for use in large vessel repair as an adjunct to sutures and staples. BioGlue is approved in Europe and other parts of the world for a wider variety of soft-tissue repairs, including liver, spleen, hernia, brain and lung surgeries.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in surgeries throughout the United States and Canada. The Company also manufactures the SynerGraft(R) vascular graft, the world's first tissue-engineered vascular replacement, which is CE-marked for distribution within the European Community. The human grafts processed by CryoLife using the SynerGraft technology are distributed in the U.S. under the trade names CryoValve(R)SG and CryoVein(R)SG.
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 in a larger test group, BioGlue will not reduce the need to re-operation due to bleeding to the same extent as in the Portland study, that future BioGlue performance with respect to soft tissue surgical procedures will prove less encouraging than current results, that surgeons will not accept and use BioGlue in soft tissue or other procedures, that additional regulatory requirements may be imposed by the FDA or other regulatory agencies, competition from other wound closure products 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, 2001.
For additional information about the company, visit CryoLife's web site: http://www.cryolife.com .
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