CardioTech International (Wilmington, Massachusetts), said 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 (Oyster Bay, New York) V-BAG vacuum-assisted soft shell venous reservoir with Gish's GBS heparin coating. The company said the new heparin coated application would be available 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. Gish also reported the results of a clinical study that concluded the Gish GBS polymer-based heparin bonded coating provided a better hemocompatible and biocompatible surface for cardiopulmonary bypass via protein and platelet preservation. The study included microscopic, spectrophotometric and electron microscopic examination of coating used in cardiopulmonary bypass circuits.

Tessera (Seattle), a biomedical company developing products for the early detection of prostate and colon cancer, said it has released its first product, ProstaMark EPCA (Early Prostate Cancer Antigen), as an analyte specific reagent for commercial use in pathology laboratories to assist pathologists in their efforts to determine if cancer is present in the prostate. Tessera's EPCA test is now available at Unipath (Denver) and will soon be offered by pathology laboratories throughout the country, as well as major prostate cancer centers. Tessera has contracted Chemicon International (Temecula, California), a subsidiary of Serologicals (Norcross, Georgia), to manufacture the ProstaMark EPCA product.

Vanguard Medical Concepts (Lakeland, Florida) reported that the FDA has determined that its reprocessed ultrasonic scalpels are "substantially equivalent" to new and has cleared the company to resume sales of the product. Vanguard voluntarily removed the scalpels from the market last fall pending an FDA request for additional documentation of the company's methodology for cleaning, testing and sterilizing the devices. At issue was whether the complex device, which is marketed for a single use, could be safely reconditioned for a limited number of additional uses and function "as new" without any health risk to patients.