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Sunshine Heart Provides Update on U.S. Pivotal Study of C-Pulse(R) Heart Assist System

EDEN PRAIRIE, Minn., April 16, 2015 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq: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.

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