Sunshine Heart has received CE mark approval for its C-Pulse heart assist system for the treatment of Class III and ambulatory Class IV heart failure (HF), which will allow for commercialization of the technology in Europe and countries in Asia and Latin America that recognize the CE mark.
The C-Pulse, which operates outside of the patient's bloodstream, utilizes the 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, according to the Sydney, Australia-based company.
The Class III HF population is estimated at 3.7 million patients in the European Union.
The company said it expects to complete its second-generation driver evaluation in Canada by the end of the third quarter 2012. Soon afterwards, Sunshine plans to initiate select centers in Europe to participate in a post-market clinical trial that it expects will generate data for reimbursement coverage.