Sunshine Heart Implants First Patient in COUNTER HF US Pivotal Trial

Sunshine Heart, Inc.

announced today the first patient implant in the Company's U.S. pivotal trial, COUNTER HF. The COUNTER HF study is a prospective, randomized, multi-center, controlled trial that will evaluate the safety and efficacy of the C-Pulse system for the treatment of 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 improve heart function and reduce re-hospitalizations due to worsening heart failure. "We are excited to be part of this innovative clinical trial," said 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. "Based on the positive clinical results from our experience during the feasibility study, we are very much looking forward to participating in the COUNTER HF pivotal study. 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