Gish Gains FDA Clearance for Heparin-Coated Blood Reservoir
CardioTech International announced that its wholly owned subsidiary, Gish Biomedical has received FDA clearance to sell a disposable soft shell venous reservoir that facilitates air removal during surgical procedures requiring extracorporeal support for up to six hours.
Gish received FDA clearance to market the Circulatory Technology V-BAG vacuum assisted soft shell venous reservoir with Gish's GBS heparin coating March 17. The company plans to offer the new heparin-coated application to customers immediately.
The use of vacuum assisted venous drainage is designed to minimize overall prime volume and surface area of the extracorporeal circuit during open-heart surgery.