Sunshine Heart Gets FDA Nod to Conduct Study of Heart Assist System

Sunshine Heart said Wednesday that it received FDA approval to conduct an interim analysis of its U.S. pivotal Counter HF study. The trial is evaluating the safety and efficacy of the C-Pulse Heart Assist system in treating New York Heart Class III and early Class IV heart failure.

Essential to the study is an assessment of C-Pulse’s unique balloon counterpulsation treatment, which is designed to improve heart function and reduce rehospitalizations, the devicemaker said.

Sunshine Heart President and CEO Dave Rosa said the FDA’s decision, which ahead of the anticipated timeframe of the end of the first quarter, has the potential to reduce the development timeline for the heart failure solution.

The prospective, randomized U.S. trial expects to enroll 388 patients in up to 40 clinical sites, Sunshine Heart said. Patients must have NYHA Class III or early IV heart failure, be taking prescribed heart failure medications, have been evaluated for cardiac resynchronization therapy and have a measurement of how well the heart pumps blood of less than 35 percent. — Kellen Owings