Minimally invasive laser fiberoptic delivery system receives FDA premarket approval

July 25, 2013

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.

BioOptics World Editors

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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BioOptics World Editors

We edited the content of this article, which was contributed by outside sources, to fit our style and substance requirements. (Editor’s Note: BioOptics World has folded as a brand and is now part of Laser Focus World, effective in 2022.)