CryoLife Receives FDA 510(k) Clearance for CryoValveÂ® SG Pulmonary Heart Valve Shelf-life Extension
ATLANTA, June 8 /PRNewswire-FirstCall/ — CryoLife, Inc., (NYSE: CRY) a biomaterials, medical device and 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 CryoValveÃ‚® SG pulmonary human heart valve processed with the Company’s proprietary SynerGraftÃ‚® technology. CryoLife’s SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix. This biotechnology is used by cardiovascular surgeons for complex reconstructive surgeries, including those performed on children.
“This shelf-life extension to five years simplifies the purchasing decisions and tissue inventory management issues presented to hospitals by the previous one-year shelf life,” said Steven G. Anderson, CryoLife’s president and chief executive officer. “Additionally, the extended shelf life will allow us more flexibility to increase the percentage of heart valves processed utilizing the SynerGraft technology. This will serve to make this technology available to more patients.”
The CryoValve SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed or malfunctioning native pulmonary valves. The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures (RVOT), commonly performed in children with congenital heart defects. In addition, the valve can be used for pulmonary valve replacement during the Ross Procedure, an operation in which a patient’s defective aortic valve is removed and replaced with his own pulmonary valve. The CryoValve SG is then surgically implanted in place of the removed native pulmonary valve.
At FDA’s request, CryoLife is continuing research on SynerGraft processed pulmonary heart valves by conducting a post-clearance study to seek evidence for the potential and implied long-term benefits. Data to be collected will include long-term safety and hemodynamic function, immune response, and explant analysis. CryoLife believes that this information may help it ascertain whether the SynerGraft process reduces the immunogenicity of the transplanted heart valve and allows the valve to recellularize with the recipient’s own cells.
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 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 hospital purchasing decisions and on CryoLife’s flexibility to increase the percentage of heart valves processed utilizing the SynerGraft technology. 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 CryoValve 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, and tissue processing decisions are also impacted by a number of factors, including procurement rates and tissue demand, and as a result, the percentage of heart valves processed may not increase as expected. CryoLife’s business is also subject to a number of risks and uncertainties, including those risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K filing for the year ended December 31, 2009 and Form 10-Q for the quarter ended March 31, 2010. The Company does not undertake to update its forward-looking statements.
For additional information about the company, visit CryoLife’s Web site:
Media Contacts: D. Ashley Lee Jerry Tolk Executive Vice President, Chief Financial Officer and Senior Vice President Chief Operating Officer Edelman Health Phone: 770-419-3355 Phone: 404-832-6349 Jerry.Tolk@edelman.com
SOURCE CryoLife, Inc.