Sunshine Heart has successfully implanted first patient with C-Pulse system in the COUNTER HF, a prospective, randomised, multi-centre, controlled trial designed to evaluate the safety and efficacy of the C-Pulse system for the treatment of New York Heart Class (NYHA) Class III and ambulatory Class IV heart failure.
As part of the study, C-Pulse’s unique balloon counterpulsation treatment will be evaluated for improvement in heart function and reduction in re-hospitalisations caused by worsening heart failure.
The study is expected to enrol 388 patients in up to 40 clinical sites in the US who meet certain key study qualifications such as NYHA Class III or early Class IV heart failure, ejection fraction, taking appropriate heart failure medications as prescribed by doctor, and have been evaluated for cardiac resynchronisation therapy with or without defibrillation or implantable cardioverter defibrillator therapy.
The C-Pulse system includes cuff, sensing lead, interface lead and driver; it will assist the heart by reducing the workload of the left ventricle, while increasing blood flow to the heart muscle.
It uses balloon counterpulsation technology to increase cardiac output, coronary artery blood flow and reduce the heart’s pumping workload.
The potential benefits of the technology, which are currently being analysed in clinical trials, are relief of shortness of breath, increased physical activity, and improved cardiac functions.
In comparison with other devices used for circulatory support, the C-Pulse system offers the advantage of implantation through a truly minimally invasive approach without any incisions into the heart itself or to any major vessels.
Its non-blood contacting interface allows patients to disconnect the device for short periods of time.
Sunshine Heart CEO David Rosa said the COUNTER HF study is important for the many heart failure patients who are not being successfully treated with existing therapies.
"We are pleased to have St Luke’s Mid-America Heart Institute enrol and implant our first patient in the COUNTER HF pivotal trial," Rosa said.
According to GlobalData estimates, the left ventricular assist devices market in the US, which was valued at $361.6m in 2012 and is expected to grow at a CAGR of 15.1% to reach $967m by 2019.