Sunshine Heart has announced that it has filed its submission for an investigational device exemption (IDE) with the US Food and Drug Administration (FDA) to undertake a pivotal trial of its C-Pulse Heart Assist System for patients suffering with moderate to severe heart failure.
If successful, the company believes this trial should provide the data required by the FDA to permit approval for comercialisation of the system in the USA.
This pivotal trial follows the FDA’s review of the six month safety and efficacy data reported from the 20-patient North America feasibility study. In March 2012, the FDA completed its review of the C-Pulse System feasibility trial data and concluded that applicable requirements had been met for the company to move forward with an IDE application for its pivotal trial.
Bill Abraham, Ohio State University Medical Center, will be the national principal investigator for this proposed 388 patient pivotal trial. The primary endpoint is reduction of events such as re-hospitalisation due to worsening heart failure and heart failure-related mortality. The study will evaluate results for patients that receive the C-Pulse System in comparison to a control group that is managed on optimal medical therapy.
About the C-Pulse Heart Assist System
The C-Pulse Heart Assist System utilises the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries.
Operating outside the patient’s bloodstream, the extra-aortic approach of the C-Pulse technology offers greater flexibility, allowing patients to safely disconnect to have intervals of freedom to perform certain activities such as showering. 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.