Gish gets US nod for heparin-coated cardioplegia technology:
This article was originally published in Clinica
Executive Summary
Gish Biomedical has completed its line of heparin-coated Vision products for heart-lung bypass surgery, after gaining US FDA 510(k) clearance for its blood cardioplegia (VBC) system. The product incorporates a heat exchanger design that offers greater than 90% heat exchange efficiency at 250ml/min blood flow. It also includes an integrated bubble trap. Gish, a subsidiary of Wilmington, Massachusetts-based CardioTech International, believes that the potential market for heart-lung bypass products could reach $200m annually. The entire heart-lung products market is estimated at $500m annually.
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