Sunshine Heart has reported the first patient implant in the company's US pivotal trial, COUNTER HF. The first patient was enrolled and implanted at the St Luke's Mid-America Heart Institute. COUNTER HF is a prospective, randomised, multicentre, controlled study that will evaluate the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure. Integral to COUNTER HF is the assessment of C-Pulse's balloon counterpulsation treatment designed to improve heart function and reduce re-hospitalisations due to worsening heart failure.
The C-Pulse system, in comparison with other devices used for circulatory support, offers the advantage of implantation through a minimally-invasive approach without the need for cardiopulmonary bypass or sternal division. Its non-blood contacting interface obviates the need for anticoagulation and allows patients to untether from the device for short periods of time.
COUNTER HF is expected to enrol 388 patients in up to 40 clinical sites. The purpose of the study is to determine whether the C-Pulse system is a safe and effective treatment for heart failure patients who meet the following key study qualifications:
â¢ NYHA Class III or early Class IV heart failure;
â¢ ejection fraction <=35%;
â¢ taking appropriate heart failure medications as prescribed by doctor; and
â¢ have been evaluated for cardiac resynchronisation therapy with or without defibrillation or implantable cardioverter defibrillator therapy.
The C-Pulse system is an investigational treatment and is a unique approach for treating moderate to severe heart failure. It uses proven balloon counterpulsation technology to assist the heart by reducing the workload of the left ventricle, while increasing blood flow to the heart muscle. The C-Pulse system does not replace the heart function, but rather is designed to assist the heart in doing its job. The system includes the following key components: cuff, sensing lead, interface lead and driver.
The C-Pulse cuff wraps around the outside of the ascending aorta. It is connected to the driver (the pump) by a tube (interface lead) that passes through a small hole in the skin. The C-Pulse cuff pumps in rhythm with the natural heartbeat, which is monitored using a pacemaker-type wire, called a sensing lead. The cuff deflates just before the heart pumps blood, reducing the workload of the heart. The cuff is timed to re-inflate in between heartbeats, once the heart has finished pumping blood. This allows the cuff to act like a second heartbeat, producing a surge of blood flow to the heart muscle. The driver includes a small rechargeable battery, which provides the power for the C-Pulse system.
Combined, these potential benefits may reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices. There is an additional long-term benefit of having patients discontinue use of the device due to sustained improvement in their condition as a result of the therapy. This occurred in some feasibility study patients.
The C-Pulse system is implanted without any incisions into the heart itself or to any major vessels. It does not come in contact with the internal blood system. Patients can disconnect with it for short periods of time if needed. It may be used in combination with other approved devices and medications for treating heart failure.
Sunshine Heart has completed an approved FDA feasibility clinical trial of the C-Pulse system and presented the results in November 2011. In March 2012, the FDA notified the company that it could move forward with an IDE application, which then received unconditional approval from the FDA in November 2012, to initiate its pivotal study. In July 2012, Sunshine Heart received CE mark approval for its C-Pulse system.