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.
