CardioTech International's wholly owned subsidiary, Gish Biomedical Inc. (Gish) has received FDA clearance to sell a disposable soft shell venous reservoir, which facilitates air removal during surgical procedures requiring extracorporeal support for up to six hours. Gish received FDA clearance to market the Circulatory Technology, Inc. V- BAG vacuum assisted soft shell venous reservoir with Gish's proprietary GBS heparin coating and plans to launch the device 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.
Gish also reported the results of a clinical study that concluded the GBS polymer-based heparin bonded coating provided a better hemocompatible and biocompatible surface for cardiopulmonary bypass via protein and platelet preservation. This study was presented at both the February CREF meeting in San Diego and the March AmSECT meeting in New Orleans.
Drs Serdar Gunaydin, Kevin McCusker and V Vijay, co-authored a paper entitled, "Clinical Performance and Biocompatibility of Novel Heparin Bonded Coating Technology." The clinical study included microscopic, spectrophotometric and electron microscopic examination of coating used in cardiopulmonary bypass circuits.
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