Sunshine Heart Announces FDA Approval to Resume Enrollment in Pivotal Study

Sunshine Heart Announces FDA Approval to Resume Enrollment in COUNTER HF™ US Pivotal Study for C-Pulse® Heart Assist System

EDEN PRAIRIE, Minn.,  (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) is pleased to announce that the US Food and Drug Administration (FDA) has approved the resumption of patient enrollment in its COUNTER HF US pivotal study for the C-Pulse Heart Assist System. As such, the Company has already begun the process to provide all pivotal study centers with the information required for their Investigational Review Board to approve the continuation of study enrollment.

“Resuming enrollment in COUNTER HF has been our top priority and was accomplished within the timelines originally announced. The proposed protocol modifications have enhanced an already robust protocol, and should increase the likelihood of success. We are encouraged by our investigators’ enthusiasm as witnessed by the high site representation at our recent investigator meeting,” commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.

Earlier in February 2015 the FDA unconditionally approved an interim analysis for the COUNTER HF study, as a means to potentially reduce the approval timeline for the C-Pulse therapy. FDA approval to resume study enrollment will now allow the Company to progress expeditiously towards that goal.

Individuals who are interested in exploring if they might qualify for COUNTER HF can visit or call 1-888-978-8391.

About the COUNTER HF and OPTIONS HF Studies:

COUNTER HF is a prospective, randomized, multi-center clinical study. It is being conducted by heart failure and cardiac surgeon specialists in the United States. It is expected to randomize 388 patients in up to 40 clinical sites. The purpose of the study is to determine whether the C-Pulse System is a safe and effective treatment for heart failure patients who meet the following key study qualifications:

  • NYHA Class III or early Class IV heart failure*;
  • Ejection fraction ≤ 35% (measure of how well the heart pumps blood);
  • Taking appropriate heart failure medications as prescribed by doctor; and
  • Have been evaluated for cardiac resynchronization therapy with or without defibrillation (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) therapy.

*New York Heart Class (NYHA) Class III or early Class IV: Very limited in daily activities or unable to do activities without discomfort. Become tired, short of breath, and have heart palpitations during physical activity. Note: Other qualifications apply and study doctors will determine who is eligible for the study.

OPTIONS HF is a post-market, multi-center, prospective, open label study that will include 50 patients in up to 15 European centers. The study is designed to observe clinical outcomes of heart failure patients treated with the C-Pulse system. The primary endpoint is comparable to the COUNTER HF study as it evaluates the rate of re-hospitalization due to worsening heart failure and heart failure related death in addition to many other traditional heart failure endpoints.

About the C-Pulse® Heart Assist System

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.