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

EDEN PRAIRIE, Minn., May 26, 2015 (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 Boardto approve the continuation of study enrollment.

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