Sunshine Heart Inc. announced an update in late July on its COUNTER HF U.S. 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 New York Heart Association (NYHA) Class III and ambulatory Class IV heart failure. The study was temporarily paused this past March after the company notified the U.S. Food and Drug Administration (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.