St. Jude/Hancock Jaffe Laboratories
This article was originally published in The Gray Sheet
Executive Summary
Firms' joint venture, The Heart Valve Company, commences international clinical trials with the first implantation of its SJM X-Cell heart valve bioprothesis March 17 at Glenfield Hospital in Leicester, England. The valve incorporates "an antimineralization process which removes potential calcification sites from the valve tissue," and "a special sterilization process that significantly simplifies the rinse procedure for the valve before implantation, thereby saving valuable operating room time," St. Jude claims. Clinicals will expand to other European centers "shortly," leading to a possible IDE application in 1994, according to the firm ("The Gray Sheet" March 7, I&W-3)