Sunshine Heart of Eden Prairie, MN received European clearance for its C-Pulse cardiac assist device for use in patients with Class III and ambulatory Class IV heart failure. The pump is uniquely designed to wrap around the ascending aorta and help the left ventricle do its work without directly coming in contact with the pumped blood. Beside the clinical benefits of this approach, such as potentially reduced chances of blood clotting, the extra-aortic counter-pulsation technology allows patients to temporarily turn off and disconnect the system from the power supply as needed for bathing and other tasks.
According to the company, “The C-Pulse System may help maintain the patient’s current condition and, in some cases, reverse the heart failure process, thereby potentially preventing the need for later stage heart failure therapies, such as left ventricular assist devices (LVADs), artificial hearts or transplants.”
Sunshine Heart is also actively navigating the FDA’s approval process and is expecting to initiate a pivotal trial in the coming months:
We have completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical trial of the C-Pulse System and presented the results in November 2011. In March 2012, the FDA notified us that we can move forward with an investigational device exemption (IDE) application. We expect to submit an IDE application to the FDA in the second half of 2012 for approval to initiate our pivotal trial.
Product page: C-Pulse Heart assist system