Archive for the 'Patient Monitoring' Category

Boston Scientific’s Advanced Devices to Treat Heart Failure and Sudden Cardiac Death in Availability

Boston Scientific CorporationBoston 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 Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)

CryoLife, Inc.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.

NiTi Surgical Solutions Introduces Investigational Bowel Anastomosis Device

NiTi Surgical SolutionsNiTi Surgical Solutions showcased new, investigational bowel anastomosis device at the American College of Surgeons (ACS) 95th Annual Clinical Congress. The device, which will be marketed as BowelRing, represents the company`s next advancement in its innovative BioDynamix Anastomosis Technology platform. NiTi`s unique line of products utilizes Nitinol-based elements to press together the ends of resected tissue, enabling natural reconnection and healing after removing a section as part of a surgery.