Minimally invasive laser fiberoptic delivery system receives FDA premarket approval

Tissue processing and medical device company CryoLife has received FDA premarket approval for its Sologrip minimally invasive laser fiberoptic delivery system, which is a single-use, disposable handset designed for use with the company's Cardiogenesis transmyocardial revascularization (TMR) system.

Tissue processing and medical device company CryoLife (Atlanta, GA) has received FDA premarket approval for its Sologrip minimally invasive laser fiberoptic delivery system, which is a single-use, disposable handset designed for use with the company's Cardiogenesis transmyocardial revascularization (TMR) system.

Related: Clinical TMR + stem cell delivery tests basis for Cardiogenesis' U.S. strategy

CryoLife's subsidiary, Cardiogenesis Corporation, specializes in treatment of cardiovascular disease and in devices that treat severe angina. Its YAG laser system and single-use fiberoptic 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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