Sunshine nets FDA trial approval for Class III heart failure device

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Sunshine Heart, a medical device company focused on heart assist technologies, has received FDA approval for a 20-person clinical trial for its C-Pulse heart assist system to treat Class III heart failure.

The Sydney, Australia-based Sunshine said that its C-Pulse is an implantable, non-blood contacting, heart assist therapy for the treatment of people with moderate heart failure.

C-Pulse reduces the symptoms of heart failure through the use of counterpulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and reduction in the heart's pumping workload, according to the company.

The Ohio State University Medical Center in Columbus, Ohio, has completed the first two implants of Sunshine's C-Pulse systems. The systems were implanted by Benjamin Sun, MD, chief of the division of cardiothoracic surgery and director of cardiac transplantation and mechanical support at Ohio State.

The 20-patient feasibility clinical trial is being undertaken at six U.S. medical institutions: Northwestern Memorial Hospital in Chicago, Ohio State; Jewish Hospital University (University of Louisville in Ky.), Hershey Medical Center of the Pennsylvania State University in Hershey, Pa., University of Florida School of Medicine in Jacksonville and University of Alabama/ Birmingham Medical Center.