The US Food and Drug Administration (FDA) has granted conditional approval to Sunshine Heart to conduct an investigational device exemption (IDE)) clinical study on its implantable heart assist device, designed to treat heart failure.
By utilising the intra-aortic balloon counter-pulsation applied in an extra-aortic approach, the non-blood contacting C-Pulse Heart Assist device relieves symptoms of heart failure and increases cardiac output and coronary blood flow while reducing the heart's pumping load.
The IDE study, which is expected to commence in the fourth quarter of 2012, will enrol 388-patients of which half will be implanted with the C-Pulse system, while the other half will be randomised 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 hospitalisation, 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 enrolment 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 Centre cardiovascular medicine division director and study principal investigator Dr William Abraham said he is excited to return to play an integral role in C-Pulse's final stages of development, having led the C-Pulse feasibility study last year and witnessed the potential of the device.
"With a large and growing population of C-Pulse eligible patients and hospitals facing financial penalties for high heart failure re-hospitalisation 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," Abraham said.