The US Food and Drug Administration (FDA) has granted conditional approval to Sunshine Heart’s new C-Pulse system driver, designed to provide moderate to severe heart failure patients with enhanced patient comfort and performance.
The new driver features a lighter, quieter single unit which is approximately half the size of its predecessor, as well as a number of software enhancements.
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 the new driver in its Canadian study at the 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 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, according to the company.
The implantable, non-blood contacting, heart assist C-Pulse device utilises 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 the heart’s pumping load.
The C-Pulse device also helps in maintaining a patient’s current condition and, in some cases, reverse the heart failure process, thereby preventing the need for later stage heart failure therapies such as left ventricular assist devices, artificial hearts or transplants.