CryoLife Receives FDA 510(k) Clearance for CryoPatchÂ® SG Pulmonary Human Cardiac Patch Shelf-life Extension
ATLANTA, Aug. 9 /PRNewswire-FirstCall/ — CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for a five-year shelf-life on its CryoPatchÃ‚® SG pulmonary human cardiac patch processed with the Company’s proprietary SynerGraftÃ‚® technology. CryoLife’s SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix.
“This shelf-life extension allows us to make this advanced technology available to more patients,” said Steven G. Anderson, CryoLife’s president and chief executive officer. “Further, the extended five-year shelf life will simplify the purchasing decisions and tissue inventory management for hospitals.”
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 can pose a significant risk to future organ transplant patients.
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 CryoValveÃ‚® SG pulmonary heart valve, processed using CryoLife’s proprietary SynerGraftÃ‚® technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. The Company’s CryoPatchÃ‚® SG pulmonary human cardiac patch has FDA 510(k) clearance 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. The Company’s BioGlueÃ‚® 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(TM) 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 AestheticÃ‚® 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 currently distributes HemoStaseÃ‚®, a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in many international markets 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 the impact of the five year shelf life on purchasing decisions and tissue inventory management for hospitals, and 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, hospital purchasing decisions are impacted by a number of factors, including price and reputation, and as a result may not be significantly impacted by the increased shelf life. CryoLife’s business is also subject to a number of risks and uncertainties, including the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-Q to be filed for the quarter ended June 30, 2010, our Form 10-Q filing for the quarter ended March 31, 2010 and our Form 10-K filing for the year ended December 31, 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.
Media Contacts: D. Ashley Lee Dana Hartline Executive Vice President, Chief Financial Officer and Vice President Chief Operating Officer Edelman Phone: 770-419-3355 Phone: 404-832-6358 Dana.Hartline@edelman.com
SOURCE CryoLife, Inc.