Sunshine Heart gets FDA approval to conduct Counter HF study of C-Pulse system

25 February 2015 (Last Updated February 25th, 2015 18:30)

US-based medical device firm Sunshine Heart has received approval from US Food and Drug Administration (FDA) to carry out an interim analysis of Counter HF study of the C-Pulse Heart Assist System (C-Pulse system).

US-based medical device firm Sunshine Heart has received approval from US Food and Drug Administration (FDA) to carry out an interim analysis of Counter HF study of the C-Pulse Heart Assist System (C-Pulse system).

The prospective, randomised, multi-centre, controlled Counter HF study is designed to evaluate safety and efficacy of the C-Pulse system to treat New York Heart Association (NYHA) Class III and ambulatory Class IV heart failure.

According to the company, integral to the Counter HF study is the evaluation of C-Pulse's balloon counterpulsation treatment that is designed to improve heart function, as well as reduce re-hospitalisations due to worsening heart failure.

Sunshine Heart president Dave Rosa said: "Today's announcement is a significant achievement for the company as it offers the potential to dramatically reduce the development timeline for this important solution for heart failure.

"Conducted by heart failure and cardiac surgeon specialists in the US, the trial is expected to randomise 388 patients in 40 clinical sites."

"The FDA decision to approve this interim analysis is not only unconditional, but also arrives earlier than the originally anticipated timeframe of the end of Q1 2015."

Conducted by heart failure and cardiac surgeon specialists in the US, the trial is expected to randomise 388 patients in 40 clinical sites. The trial is aimed at determining whether the C-Pulse system is a safe and effective treatment for heart failure patients.

The trial is for patients who meet study qualifications including NYHA Class III or early Class IV heart failure, ejection fraction =35%, taking appropriate heart failure medications as prescribed by the doctor; and have been evaluated for cardiac resynchronisation therapy with or without defibrillation (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) therapy.

The C-Pulse System is an investigational device in the US, Canada and countries that do not recognise the CE Mark approval.

The system uses the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to coronary arteries.