Sunshine Heart has submitted an investigational device exemption (IDE) application of its C-Pulse Heart Assist system to the US Food and Drug Administration (FDA) for approval.
The basis of the IDE application is for the initiation of the company's proposed 388 patient pivotal trial, designed to demonstrate results for patients who receive the C-Pulse system in comparison to a control group that is managed on optimal medical therapy.
The IDE submission was based on the completion of review of C-Pulse system's feasibility trial data by the FDA in March 2012.
Reduction of events such as re-hospitalization due to worsening heart failure and heart failure-related mortality are the proposed primary endpoints for the study.
The study will follow the FDA's review of the six month data reported from the 20-patient North America feasibility study, designed to review the safety and efficacy of C-Pulse system.
The company said the pivotal trial is expected to provide the data required by the FDA to permit approval, which will allow the company to commercialize its C-Pulse system in the US.
C-Pulse Heart Assist system, an implantable, non-blood contacting device, is designed to relieve symptoms of moderate to severe heart failure through the use of counter-pulsation technology, which enables an increase in cardiac output; an increase in coronary blood flow; and a reduction in the heart's pumping load.
