Update US Study

http://www.globenewswire.com/news-r...-Study-for-C-Pulse-R-Heart-Assist-System.html

EDEN PRAIRIE, Minn., July 23, 2015 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (NASDAQ:SSH) announced today an update on its COUNTER HF™ US pivotal study for the C-Pulse Heart Assist System. 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 was temporarily paused this past March after the Company notified the FDA of four deaths in the treatment arm of the study. The deaths were adjudicated as not device or therapy related and as previously announced on May 26th, the FDA approved resumption of patient enrollment in the study.
"I'm pleased with the enthusiasm and speed at which sites are being reactivated. We witnessed genuine excitement for the study at our recent investigator meeting and are strongly encouraged by the momentum generated at many of our sites," commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.
Immediately following the FDA's decision to approve enrollment to continue the COUNTER HF's study, Sunshine Heart distributed material to all sites with the necessary documentation in order to achieve site Investigational Review Board (IRB) approvals. Currently, 12 sites have been reactivated which is approximately half of all previously activated sites. Sunshine Heart expects the majority of sites to be reactivated by the end August. In addition, the Company is pleased to announce the enrollment of its first two patients since the resumption of the COUNTER HF study. One of these patients was already reviewed by Sunshine Heart's newly formed Physician Subject Selection Committee. This process was handled efficiently and led to the first implant being scheduled for this morning.
About the COUNTER HF Study