[IMG] Sunshine Heart Provides Update on U.S. Pivotal Study of...

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Sunshine Heart Provides Update on U.S. Pivotal Study of C-Pulse(R) Heart Assist System EDEN PRAIRIE, Minn., March 6, 2015 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) today announced an update on COUNTER HF™, the Company's U.S. pivotal study which 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 Company continues to experience increased interest from the medical and patient community regarding participation in the COUNTER HF study. In fact, over the past twelve months, the number of patients considering enrollment in this study has dramatically increased from 7 in Q1 2014 to approaching 100 for the first quarter in 2015.While Sunshine Heart is pleased with the study's progress in terms of the recent enrollment pace and site interest, it will be taking a temporary pause from enrollment. This is in accordance with the study protocol where in the event more than three of the first twenty subjects pass away for any reason, including non-device related deaths, the Company will work with the FDA to discuss a plan to resume enrollment. To date, of the four reported patient deaths, two have been adjudicated by an independent Clinical Events Committee (CEC) as being non-device related. The Company has received study documentation from the sites that reported the most recent two deaths that these were also non-device related. Patients already in the trial will continue follow-up according to the protocol.The FDA has responded to Sunshine Heart's notification and has advised the Company to file an IDE supplement that discusses the reasons for the temporary study suspension and a plan for study resumption. A supplement carries up to a 30-day review period by the FDA and the Company expects to submit the document by March 16, 2015."We are confident this matter will be resolved in a very short timeframe. While the current data suggest these incidents are non-device related, we have decided that in the absolute interest of patient safety, having a temporary pause in enrollment is the right course of action while we work with the FDA to discuss the findings. We remain excited by the increasing number of patients who are being presented for study review and are pleased that the screening process for enrollment will continue while we resolve this matter," commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.Sunshine Heart will host its 2014 Q4 results conference call on March 17, 2015 following the submission of the COUNTER HF supplement document to the FDA. At this time, the Company's management team and Dr. Bill Abraham, one of the Study's Principal Investigators, will be available to address questions as part of the standard quarterly conference call format.