The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health(CDRH) said it has completed the review of Sunshine Heart's investigation device exemption(IDE) for the C-Pulse heart assist system feasibility trial.
The C-Pulse heart assist system utilizes the intra-aortic balloon counter-pulsation technology to reduce symptoms associated with Class III and ambulatory Class IV heart failure.
The feasibility study, which enrolled 20 patients, was designed to assess the safety and efficacy of C-Pulse heart assist system in treating moderate to severe heart failure patients who suffer from symptoms including shortness of breath and reduced mobility.
The results demonstrated that the C-Pulse therapy produced considerable improvements in NYHA class reduction, quality of life, and left ventricular ejection fraction which measures the heart’s pumping ability.
The FDA reported Sunshine that it has met the requirements of its regulation 21CFR 812.150(b)(5).
Sunshine Heart CEO Dave Rosa said the company has fulfilled the agency’s requirements and look forward to work with the FDA regarding the submission of its pivotal trial protocol.
The company said it is planning to start C-Pulse US pivotal trial in the third quarter of 2012.