News | February 25, 2015

FDA Approves Interim Analysis of U.S. Pivotal Trial of C-Pulse Heart Assist System

Study will evaluate efficacy of C-Pulse in heart failure treatment

Sunshine Heart, C-Pulse, COUNTER HF, study, FDA, heart failure

February 25, 2015 — Sunshine Heart Inc. announced it has received unconditional approval from the U.S. Food and Drug Administration (FDA) to conduct an interim analysis of COUNTER HF, the company's U.S. pivotal study. The COUNTER HF study is a prospective, randomized, multi-center, controlled study that evaluates the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure. Integral to the COUNTER HF study is the assessment of C-Pulse's balloon counterpulsation treatment designed to improve heart function and reduce re-hospitalizations due to worsening heart failure.

A key potential benefit of conducting the analysis is the prospect of reducing the overall duration of the study should COUNTER HF meet the higher statistical threshold of the interim analysis. The study is a prospective, randomized, multi-center clinical trial. It is being conducted by heart failure and cardiac surgeon specialists in the United States and is expected to randomize 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:

  • NYHA Class III or early Class IV heart failure;
  • Ejection fraction less than or equal to 35 percent (measure of how well the heart pumps blood);
  • Taking appropriate heart failure medications as prescribed by doctor; and
  • Have been evaluated for cardiac resynchronization therapy with or without defibrillation (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) therapy.


The C-Pulse Heart Assist System utilizes 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 the coronary arteries. Combined, these potential benefits may help sustain the patient's current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function.

For more information: www.hfclinicalstudy.com


Related Content

News | Cardiovascular Clinical Studies

July 18, 2024 — Elucid, a pioneering AI medical technology company providing physicians with imaging analysis software ...

Home July 18, 2024
Home
News | Cardiovascular Clinical Studies

July 10, 2024 — CellProthera, a private company specializing in cell-based therapies for repairing ischemic tissues, and ...

Home July 10, 2024
Home
News | Cardiovascular Clinical Studies

July 9, 2024 — Microbot Medical Inc. announced the completion of the first procedure in a patient utilizing its LIBERTY ...

Home July 09, 2024
Home
News | Cardiovascular Clinical Studies

June 26, 2024 — Semaglutide, a medication initially developed for type 2 diabetes and obesity, significantly improves ...

Home June 26, 2024
Home
News | Cardiovascular Clinical Studies

June 21, 2024 — Lexicon Pharmaceuticals, Inc. announced that the peer-reviewed Journal of the American College of ...

Home June 21, 2024
Home
News | Cardiovascular Clinical Studies

June 20, 2024 — Microbot Medical Inc. announced its agreement with Brigham and Women’s Hospital (BWH), a leading ...

Home June 20, 2024
Home
News | Cardiovascular Clinical Studies

June 20, 2024 — A programming algorithm, being tested by HonorHealth Research Institute for those patients with new or ...

Home June 20, 2024
Home
Videos | Cardiovascular Clinical Studies

As part of DAIC's continuing Thought Leadership Series, this month Editorial Director Melinda Taschetta-Millane sits ...

Home June 12, 2024
Home
News | Cardiovascular Clinical Studies

June 6, 2024 —Cleveland Clinic researchers found higher amounts of the sugar alcohol xylitol are associated with ...

Home June 06, 2024
Home
Subscribe Now