CryoLife Receives FDA Premarket Approval (PMA) for New Sologrip Minimally Invasive TMR Laser Fiber-Optic Delivery System
ATLANTA, July 10, 2013 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today that it has received U.S. Food and Drug Administration (FDA) premarket approval for its new Sologrip® minimally invasive laser fiber-optic delivery system. The Sologrip delivery system is a single-use, disposable handset designed for use with the Company's Cardiogenesis transmyocardial revascularization (TMR) system.
"We are pleased to receive FDA approval for our updated Sologrip handset. We believe it will be well received by our customers and we look forward to continuing our efforts to increase adoption of this important treatment option for patients with angina," said Steven G. Anderson, chairman, president and CEO of CryoLife.
CryoLife's subsidiary, Cardiogenesis Corporation, specializes in the treatment of cardiovascular disease and is a leader in devices that treat severe angina. Its market leading YAG laser system and single use fiber-optic delivery systems are used to perform an FDA-cleared surgical procedure known as TMR, which treats patients with angina that is not responsive to standard medications. Patients undergoing TMR treatment with Cardiogenesis products have been shown to have angina improvement, longer event-free survival, reduction in cardiac related hospitalizations, and increased exercise tolerance.
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., certain countries in Europe, and Canada. CryoLife's CryoValve® SG pulmonary heart valve, processed using CryoLife's proprietary SynerGraft® technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. CryoLife's CryoPatch® SG pulmonary cardiac patch has FDA 510(k) clearance for the repair or reconstruction of congenital heart defects. CryoLife'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. BioGlue is also CE marked in the European Community for use in soft tissue repair and approved in Japan for use in the repair of aortic dissections. Additional marketing approvals for BioGlue have been granted in several other countries throughout the world. CryoLife, through its subsidiary Cardiogenesis Corporation, specializes in the treatment of coronary artery disease for severe angina using a laser console system and single use, fiber-optic handpieces to perform a surgical procedure known as Transmyocardial Revascularization (TMR). In addition, CryoLife and its subsidiary Hemosphere, Inc. market the HeRO® Graft, which is a solution for end-stage renal disease in certain hemodialysis patients. CryoLife distributes PerClot®, an absorbable powdered hemostat, in the European Community and other select international countries. CryoLife's BioFoam® Surgical Matrix is CE marked in the European Community for use as an adjunct to hemostasis in cardiovascular surgery and on abdominal parenchymal tissues (liver and spleen) when control of bleeding by ligature or conventional methods is ineffective or impractical.
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. Such forward-looking statements reflect the views of management at the time such statements are made and are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations. These statements include those regarding our belief that Sologrip will be well received by our customers, and our efforts to increase adoption of TMR. Applicable risks and uncertainties include that our ability to drive TMR adoption is dependent upon patient and physician acceptance of TMR as a safe and effective product for use in treating angina. In addition, competitors may develop and market products and services that are perceived as being better suited, more cost effective or safer than TMR, and the Sologrip delivery system may not be perceived as desirable or as a sufficient reason to utilize TMR as opposed to a competing product or service, and regulators, including the FDA, may impose additional requirements on us to allow us to continue to market TMR and the Sologrip delivery method. CryoLife is also subject to the general risks associated with our business, including the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2012 and subsequent filings. CryoLife does not undertake to update its forward-looking statements.
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SOURCE CryoLife, Inc.