CryoLife Wins FDA Premarket Approval for New Sologrip Minimally Invasive TMR Laser FO Delivery System
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.
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