CardiacAssist receives FDA IDE approval for use of the TandemHeart system in pivotal clinical study


CardiacAssist announced on 18 December 2012 that it received investigational device exemption (IDE) approval from the FDA for a pivotal clinical study of the TandemHeart circulatory support system. The TRIS (TandemHeart to Reduce Infarct Size) trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients who have suffered a severe heart attack.

“The approval of the pivotal TRIS Trial represents a major milestone for our company and the industry,” said John Marous, president and CEO of CardiacAssist. “With the completion of our pre-clinical animal studies, which showed a strong correlation between high degrees of ventricular unloading and improved myocardial salvage, we are excited to extend this concept to human trials and hopefully achieve similar clinical benefits.”

Patients enrolled in the TRIS trial will be randomised to receive either conventional therapy or a TandemHeart device to unload the left ventricle along with percutaneous coronary intervention (PCI). The primary efficacy endpoint of the study is improvement in myocardial salvage index (MSI). 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 TRIS trial is expected to begin enrolment in early 2013 and will include up to 20 hospitals, with leadership from principle investigators Biswajit Kar, chief of the Center for Advanced Heart Failure at Memorial Hermann Heart and Vascular Institute in Houston, USA, and David Holmes, professor of Medicine at the Mayo Clinic College of Medicine in Rochester, USA, and immediate past president of the American College of Cardiology (ACC).