W.L. Gore and Associates (Gore) has announced that it has received European CE Mark approval for the next generation GORE TAG® Thoracic Endoprosthesis. The device is available in an expanded portfolio of sizes to meet a broad range of patient needs and was engineered to treat multiple etiologies including thoracic aortic aneurysms (TAAs), traumatic aortic transections and thoracic aortic dissections.

Irvine-based Endologix has received Investigational Device Exemption conditional approval from the U.S. Food and Drug Administration to begin a clinical trial for a fully percutaneous approach to endovascular abdominal aortic aneurysm repair. The authorization allows the minimally invasive device maker to test the procedure using its IntuiTrak endovascular delivery system. AAA is a weakening of the walls of the aorta, which is the largest artery in the body.

Boston Scientific Corporation has announced the launch of its COGNIS® cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN® implantable cardioverter defibrillator (ICD) in Japan. These devices were approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) in August and received reimbursement approval in September. COGNIS and TELIGEN are the result of a multi-year research and development effort to provide physicians enhanced clinical options for their patients.

CryoLife, Inc. has announced that the FDA has approved the company’s Investigational Device Exemption to conduct a human clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology.  BioFoam will be used to seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent.