Sunshine Heart is planning to initiate a US pivotal trial on its C-Pulse Heart Assist device in the fourth quarter of 2012, as it received an unconditional approval from the US Food Drug Administration (FDA).
The CE marked system, which uses an intra-aortic balloon counter-pulsation applied in an extra-aortic approach, is designed for treating Class III and ambulatory Class IV heart failure.
In addition, the device increases cardiac output, coronary blood flow and reduces the heart’s pumping load.
The study 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 also use the company’s new C-Pulse driver, which features a single unit and includes various software updates.
The primary endpoints for the trial include reduction in worsening heart failure events including hospitalization, advanced heart failure therapies and heart failure-related mortality.
Sunshine Heart chief executive officer and director David Rosa said, "We are pleased to have expeditiously completed the approval process with the FDA."
In addition, the patients will be followed for one year to further demonstrate the safety of the device.
All the participating trial centers will be reimbursed, as the FDA has granted CMS Category B3 designation, claims the company.