Healthcare Industry News: organ transplant
News Release - August 18, 2009
CryoLife Announces Implants of First FDA-Cleared SynerGraft(R) Processed Human Cardiac Patch MaterialATLANTA, Aug. 18 (Healthcare Sales & Marketing Network) -- CryoLife, Inc., (NYSE: CRY ) an implantable biological medical device and cardiovascular tissue processing company, today announced the first three implantations of the CryoPatch(R) SG pulmonary human cardiac patch since FDA clearance. The surgeries were performed on pediatric patients at the University of Michigan C.S. Mott Children's Hospital in Ann Arbor, MI by Richard G. Ohye, M.D., associate professor of surgery, division head, pediatric cardiovascular surgery and pediatric cardiac surgeon, University of Michigan Congenital Heart Center.
CryoPatch SG is the third tissue processed using CryoLife's SynerGraft technology platform to receive FDA clearance. The proprietary technology is designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix.
"We are very excited that SynerGraft technology is now available in cardiac patch materials for our pediatric patients," said Dr. Ohye, "We are hopeful the special processing these patches undergo will lessen the body's reaction to them and prevent future complications associated with the currently available material."
"At CryoLife, our ongoing goal is to provide surgeons and their patients with innovative options that will enhance recovery and restore health," said Steven G. Anderson, CryoLife's president and chief executive officer. "The CryoPatch SG, part of our growing portfolio of SynerGraft products, is an important step toward that goal, as it may offer a tissue reconstruction material that mitigates many of the future health issues faced by children born with heart defects."
About CryoPatch SG
CryoPatch SG is indicated for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.
Implantation of the CryoPatch SG reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody (PRA) measured at up to one year, compared to standard processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.
Avoiding elevated PRA is important for patients receiving CryoPatch SG as some may ultimately require a heart transplant. While the link between immune response and allograft tissue performance is still being debated, there is evidence that an elevated PRA poses a significant risk to future organ transplant patients. In these patients, an increased PRA can decrease the number of possible donors for subsequent organ transplants, and increase time on transplant waiting lists.
Please visit the CryoLife website at www.cryolife.com for additional information about the SynerGraft technology and CryoPatch SG.
About CryoLife, Inc.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company's CryoValve(R) SG pulmonary human heart valve, processed using CryoLife's proprietary SynerGraft(R) technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary valves. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. The Company's BioFoam(R) Surgical Matrix is CE marked in the European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. BIOGLUE Aesthetic(TM) Medical Adhesive is CE marked in the European Community for periosteal fixation following endoscopic browplasty (brow lift) in reconstructive plastic surgery and is distributed by a third party for this indication. CryoLife distributes HemoStase(TM), a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in the European Community and Canada for cardiac, vascular, and general surgery, subject to certain exclusions.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include those regarding anticipated effectiveness, benefits and indications for use of CryoPatch SG. These future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties. These risks and uncertainties include that CryoPatch SG may not perform as well as expected or provide all of the benefits anticipated, that the CryoPatch SG has a one year shelf life, and other risk factors detailed in CryoLife's Securities and Exchange Commission filings, including CryoLife's Form 10-K filing for the year ended December 31, 2008, our Form 10-Q for the quarter ended March 31, 2009, our Form 10-Q for the quarter ended June 30, 2009, and the Company's other SEC filings. The Company does not undertake to update its forward-looking statements.
For additional information about the company, visit CryoLife's Web site: http://www.cryolife.com
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