Sunshine Heart announced that its C-Pulse heart assist system has met the requirements of the United States Food and Drug Administration (FDA) regulation 21CFR 812.150(b)(5).
The announcement follows the completion of a review of Sunshine's investigation device exemption (IDE) for the C-Pulse system feasibility trial, by the Center for Devices and Radiological Health (CDRH).
The C-Pulse system is an implantable, non-blood contacting heart assist device, designed to relieve clinical symptoms associated with Class III and ambulatory Class IV heart failure, also referred to as moderate and severe failure.
The feasibility study involved 20 patients to demonstrate the safety and provide indications of the performance of the device in moderate to severe heart failure patients, who suffer from symptoms such as shortness of breath and reduced mobility.
After six months follow-up, C-Pulse therapy produced considerable improvements in quality of life and left ventricular ejection fraction, which measures the heart's pumping ability.
By employing the proven scientific principles of an intra-aortic balloon counter-pulsation technology, the heart assist device will help the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries.
The C-Pulse system may help reverse the heart failure process or maintain the patient's current condition, which may reduce the need for later stage heart failure therapies, such as left ventricular assist devices (LVADs), artificial hearts or transplants.
Sunshine Heart CEO Dave Rosa said the company has fulfilled the agency's requirements and looks forward to working with the FDA regarding the submission of the pivotal trial protocol. The company plans to commence its C-Pulse US pivotal trial in the third quarter of this year, 2012.
Headquartered in Minneapolis, US, Sunshine Heart is a medical device company focused on innovative cardiac assist therapy for the treatment of moderate to severe heart failure.