EDEN PRAIRIE, Minn., April 16, 2015 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (SSH) announced today that the U.S. Food and Drug Administration (FDA) has reviewed the Company's submission regarding the COUNTER HF's U.S. pivotal study pause and requested minor protocol changes be submitted in order to receive approval to resume patient enrollment. The FDA did not indicate concerns regarding safety of the device and requested the updated protocol include information on several minor items, the most significant of which are the details regarding the Company's proposal to incorporate a Physician Subject Selection Committee. Furthermore, the Data Safety Monitoring Board (DSMB), reviewed COUNTER HF's data and recommended continuing the Study.
"We are pleased the FDA has offered a collaborative process to enable the Study to commence in a timely manner. We were prepared for these types of minor protocol modifications and as such, we'll be submitting these amendments by early next week," commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.
Sunshine Heart previously announced on March 6, 2015, a temporary pause from enrollment in accordance with the study protocol. The protocol indicated that in the event more than three of the first twenty subjects pass away for any reason, including non-device related deaths, the Company would work with the FDA to establish a plan before resuming enrollment. All four of the reported patient deaths have been adjudicated by an independent Clinical Events Committee (CEC) as being non-device related.
COUNTER HF is a prospective, randomized, multi-center, controlled study evaluating the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure. The Study is being conducted by heart failure, electrophysiologists 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.
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