Sunshine Heart Implants First Patient In C-Pulse COUNTER HF U.S. Pivotal Study

(RTTNews) - Sunshine Heart Inc. (SSH) announced the first patient implant in its U.S. pivotal trial, COUNTER HF. The COUNTER HF study is a prospective, randomized, multi-center, controlled trial that would evaluate the safety and efficacy of the C-Pulse system to treat NYHA Class III and ambulatory Class IV heart failure. Integral to the COUNTER HF study is the assessment of C-Pulse's unique balloon counterpulsation treatment designed to enhance heart function and reduce re-hospitalizations due to worsening heart failure.

According to Cardiothoracic surgeon, Sanjeev Aggarwal, M.D., Director of Mechanical Circulatory Support and principal study investigator at Saint Luke's Mid America Heart Institute of Kansas City, "The C-Pulse system, in comparison to other devices used for circulatory support, offers the advantage of implantation through a truly minimally invasive approach without the need for cardiopulmonary bypass or sternal division. Its non-blood contacting interface obviates the need for anticoagulation and allows patients to untether from the device for short periods of time."

The C-Pulse system is an investigational treatment and is a unique approach for treating moderate to severe heart failure.