American medical device developer, Sunshine Heart, has submitted its C-Pulse Heart Assist system's investigational device exemption (IDE) application to the US Food and Drug Administration (FDA) for approval to initiate the proposed 388 patient pivotal trial.
The IDE submission was intiated following the FDA's review the C-Pulse system's feasibility trial data, with permission to move forward given in March 2012.
The proposed pivotal study, if permitted by the FDA, will will demonstrate results for patients who receive the system, in comparison to a control group that is managed on optimal medical therapy.
Sunshine said the primary objective of the study focuses on the reduction of events such as re-hospitalisation due to worsening heart failure, and heart failure-related mortality.
The pivotal study will follow the FDA's review of the six month safety and efficacy data reported from the 20-patient North America feasibility study, according to the company.
Upon successful completion, the pivotal trial will provide the data required by the FDA to permit approval, which the company believes will help in the commercialisation of the C-Pulse system in the US.
With the help of counter-pulsation technology and a minimally invasive procedure, C-Pulse Heart Assist system is believed to relieve symptoms of moderate to severe heart failure by enabling an increase in cardiac output, an increase in coronary blood flow and a reduction in the heart's pumping load.
Sunshine said the C-Pulse System, which it claims to be non-blood contacting , is implanted to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries.
In addition, the C-Pulse system may also help maintain the patient's current condition and, in some cases, reverse the heart failure process for preventing the need for later-stage heart failure therapies such as left ventricular assist devices, artificial hearts and transplants.