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Sunshine Heart Receives FDA Approval for Interim Analysis of U.S. Pivotal Trial of C-Pulse(R) Heart Assist System

EDEN PRAIRIE, Minn., Feb. 25, 2015 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) today announced it has received unconditional approval from the FDA to conduct an interim analysis of COUNTER HF, the Company’s U.S. pivotal study. The COUNTER HF study is a prospective, randomized, multi-center, controlled study that evaluates the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure. Integral to the COUNTER HF study is the assessment of C-Pulse’s unique balloon counterpulsation treatment designed to improve heart function and reduce re-hospitalizations due to worsening heart failure.

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