Sunshine Heart has obtained conditional approval for its new C-Pulse system driver from the US Food and Drug Administration (FDA).
The new driver, which features a lighter single unit and a number of software enhancements, is designed to provide moderate to severe heart failure patients with enhanced patient comfort and performance.
The conditional approval allows the company to use the C-Pulse system driver for investigational purposes in the US at all sites that are currently enrolled in its North American feasibility trial.
On 7 June 2012, the company received approval from Health Canada to use new driver in its Canadian study at Royal Victoria Hospital and to expand the number of participants in the trial to 20 patients.
Upon Institutional Review Board (IRB) approval, the company plans to provide the C-Pulse driver to all patients currently on its C-Pulse Heart Assist system at all the US sites.
The company said new driver is also expected to be used in the future US pivotal trial, once the FDA has approved the C-Pulse device investigational device exemption application in US, as well as in Europe.
Implantable, non-blood contacting, heart assist C-Pulse device utilizes the intra-aortic balloon counter-pulsation applied in an extra-aortic approach to relieve symptoms of heart failure and to increase cardiac output, coronary blood flow and reduce heart’s pumping load.