We have previously reported on C-Pulse™ Heart Assist device, an external aortic counterpulsation support system from Australian firm Sunshine Heart Company Pty Limited, designed to give an extra boost to patients with severe cardiomyopathy. The company and Ohio State University have just announced that the first two patients of a 20 patient study have been implanted with C-Pulse, which is undergoing an FDA approved clinical trial.
This heart assist system is designed for use in patients with NYHA Class III heart failure as defined by a limitation of physical activity. In a fashion similar to Intraaortic Ballon Pump, the device acts during the diastole through a wrapped cuff around the patient’s ascending aorta to provide counterpulsation action, which is thought to enable an increase in cardiac output, an increase in coronary blood flow and reduction in the heart’s pumping workload.
From the press release:
“We are excited that our clinical trial in the U.S. has started so successfully,” said Dr. William Peters, 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.” Dr. Peters went on to point out importantly 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.”
“The completion of the initial C-Pulse implants in the U.S. is a major milestone for Sunshine Heart which is the only non-blood contacting heart assist device in clinical trials,” said Don Rohrbaugh, the Company’s CEO. “The start of our clinical trial brings us one step closer toward our goal to address the large and growing unmet clinical need for an alternative heart failure treatment to improve and sustain a patient’s quality of life.” Mr. Rohrbaugh noted, “C-Pulse is designed for Class III heart failure patients and these are defined as suffering continuing debilitating symptoms despite maximum drug therapy.”
The 20 patient FDA-approved feasibility clinical trial is being undertaken at six U.S. medical institutions: Northwestern Memorial Hospital, The Ohio State Medical Center Jewish Hospital University (University of Louisville), Hershey Medical Center of the Pennsylvania State University, University of Florida School of Medicine and University of Alabama/ Birmingham Medical Center.
Press release : First Patients in United States Receive Innovative Device to Treat Moderate Heart Failure (.pdf)…
Product page: C-Pulse™ Heart Assist device…
Flashback : The Sunshine Heart C-Pulse