FDA gives Sunshine Heart green light for pivotal U.S. trial

Sunshine Heart ($SSH) will launch a pivotal U.S. clinical trial by the end of this year for its C-Pulse heart assist implant, following unconditional approval from the FDA to move ahead. The Minnesota and Australian-based company wants to use its device to treat patients with Class III and ambulatory Class IV heart failure, and will gather data on how well the product can reduce re-hospitalization rates due to worsening heart failure. Plans call for evaluating 388 patients, half of which will be implanted with C-Pulse. Story