Sunshine Heart, Inc. has announced that it has received CE Mark approval for its C-Pulse Heart Assist System for the treatment of Class III and ambulatory Class IV heart failure. The Class III heart failure population is estimated at 3.7 million patients in the European Union.
The C-Pulse Heart Assist System utilises the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Fundamentally the working end of the device is affixed to the ascending aorta where it pulses after every heart beat, thereby contributing to blood flow.
Operating outside the patient’s bloodstream, the extra-aortic approach of the C-Pulse technology offers greater flexibility, allowing patients to safely disconnect to have intervals of freedom to perform certain activities such as showering. The company says its C-Pulse System may help maintain the patient’s current condition and, in some cases, reverse the heart failure process, thereby potentially preventing the need for later stage heart failure therapies, such as left ventricular assist devices (LVADs), artificial hearts or transplants.
“We are proud to have achieved another significant milestone in the Company’s history. The CE Mark approval includes our second generation driver, cuff and other components which we believe will improve the overall device performance and ultimately patients’ quality of life,” said Dave Rosa, Chief Executive Officer of Sunshine Heart.
The company says it expects to complete second generation driver evaluation in Canada by the end of the third quarter 2012 followed by a targeted approach to European Centres to participate in a post market clinical trial with the intent of generating data for reimbursement coverage and to provide additional confirmation of performance.
In USA, the device is limited by Federal (or United States) Law to Investigational use.
Source: Sunshine® Heart Inc., Marketwire