The FDA has issued conditional approval for Sunshine Heart's C-Pulse system driver, which is designed to provide moderate to severe heart failure patients with enhanced patient comfort and performance.
The company said its new driver features a single unit that is approximately half the size of its predecessor and also features a number of software enhancements. The C-Pulse heart assist system, an investigational device in the U.S., Canada and countries that do not recognize the CE mark approval, utilizes the principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle.
Conditional approval from the FDA allows the Sydney, Australia-based company to use this next-generation driver for investigational purposes in the U.S. at all sites that are currently enrolled in Sunshine's North American feasibility trial. Sunshine plans to provide the C-Pulse driver to all patients currently on its C-Pulse device at all U.S. sites upon Institutional Review Board approval. This second-generation driver is expected to be used in the company's future U.S. pivotal trial once the FDA has approved the company's investigational device exemption, as well as in Europe.
On June 7, the company announced Health Canada approval to use its next-generation driver in its Canadian study at Royal Victoria Hospital. The company has also been granted Health Canada approval to expand the number of participants in the trial to 20 patients. All new patients enrolled in the trial and future trials will receive this updated C-Pulse driver.