TandemHeart IDE Study Approved by FDA

January 22, 2013—CardiacAssist, Inc. (Pittsburgh, PA) recently announced that it received investigational device exemption approval from the US Food and Drug Administration (FDA) for a pivotal clinical study of the company's TandemHeart circulatory support system. The TandemHeart to Reduce Infarct Size (TRIS) trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients who have experienced a severe heart attack.

CardiacAssist stated that the FDA-cleared TandemHeart system, which has been used in cardiac centers worldwide, provides left atrial cannulation to create a fully percutaneous extracorporeal blood circuit to bypass the left ventricle, augmenting the flow of blood by up to 5 L/min.

According to the company, patients enrolled in the TRIS trial will be randomized to receive either conventional therapy or a TandemHeart device to unload the left ventricle along with percutaneous coronary intervention. The primary efficacy endpoint of the study is improvement in myocardial salvage index. Additionally, the economic impact of TandemHeart therapy will be studied through secondary endpoints including long-term mortality and the rates of repeat hospitalization and implantable cardioverter-defibrillator usage. A reduction in these rates could decrease the total cost of treatment for this patient population.

The company advised that the TRIS trial is expected to begin enrollment in early 2013 and will include up to 20 hospitals. TRIS will be led by Principal Investigators Biswajit Kar, MD, and David Holmes, MD. Dr. Kar is Chief of the Center for Advanced Heart Failure at Memorial Hermann Heart and Vascular Institute in Houston, Texas. Dr. Holmes is Professor of Medicine at the Mayo Clinic College of Medicine in Rochester, Minnesota, and Immediate Past President of the American College of Cardiology.