Sunshine Heart has obtained a conditional approval from the US Food and Drug Administration (FDA) for its investigational device exemption (IDE)) implantable heart assist device.
The non-blood contacting C-Pulse Heart Assist device, which uses the intra-aortic balloon counter-pulsation applied in an extra-aortic approach, is designed to relieve symptoms of heart failure and increase cardiac output, coronary blood flow as well as reduce the heart's pumping load.
The IDE study, which is expected to be commenced in fourth quarter of 2012, will enroll 388-patients of which half will be implanted with the C-Pulse system, while the other half will be randomized to optimal medical therapy across 30-40 clinical sites.
The trial will use the company's new C-Pulse driver, which features a single unit and includes various software updates.
Reduction in worsening heart failure events including hospitalization, advanced heart failure therapies and heart failure related mortality are the primary endpoints for the trial.
The company, which is expecting a one year safety follow-up for the event-driven trial, is estimating that the patient enrollment will take approximately 2.5 years.
As the FDA has granted CMS Category B3 designation, the participating trial centres will be reimbursed by CMS and most private insurance providers, according to the company.
The Ohio State University Medical Center cardiovascular medicine division director and study principal investigator William Abraham said, "With a large and growing population of C-Pulse eligible patients and hospitals facing financial penalties for high heart failure re-hospitalization rates beginning in 2013 under the Obama Health Reform Act, the C-Pulse pivotal trial will determine if it will be beneficial to both patients and hospitals alike to improve health outcomes."
