The US Food and Drug Administration (FDA) has granted unconditional approval to Sunshine Heart to initiate a clinical study on its implantable non-blood contacting heart assist device, designed to treat Class III and ambulatory Class IV heart failure.
Using the intra-aortic balloon counter-pulsation applied in an extra-aortic approach, the CE marked C-Pulse Heart Assist device relieves symptoms of heart failure, increases cardiac output and coronary blood flow and reduces the heart's pumping load.
The pivotal study, which is expected to commence in the fourth quarter of 2012 in the US, will enroll 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 approximately half the size of its predecessor, 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 enrollment will take approximately two and a half years.
Sunshine Heart CEO Dave Rosa said the company is committed to advancing the next phase of this technology.
"We are pleased to have expeditiously completed the approval process with the FDA," Rosa said.
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.