A Medical Device Daily
Sunshine Heart (Tustin, California) reported that Ohio State University Medical Center (Columbus) has completed the first two implants of the company's C-Pulse heart assist system under a 20-person clinical trial approved by the FDA.
The 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.
"We are excited that our clinical trial in the U.S. has started so successfully," said William Peters, MD, medical director of Sunshine Heart and the inventor of C-Pulse. "We have demonstrated in prior clinical studies that the C-Pulse system increases blood flow to the body and to the heart muscle itself. We anticipate that C-Pulse will offer patients a significant improvement in quality of life."
Peters norted that the device operates without coming into direct contact with the blood, so avoiding potential complications with systems that do contact blood. A feature of the design of the C-Pulse is that patients can safely disconnect from the device for short periods for their convenience."
Sunshine Heart specializes in heart-assist therapy for the treatment of people with moderate heart failure.