October 1, 2013 — Sunshine Heart Inc. has launched a website dedicated to providing information to patients suffering from moderate to severe heart failure to learn about its C-Pulse U.S. pivotal trial, COUNTER HF(TM).
The site offers patients and family members an interactive forum to learn about the C-Pulse system, including qualification criteria, a prescreening questionnaire and information detailing how to enroll in the trial.
The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counterpulsation 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. Based on the results from our feasibility trial, some patients treated with our C-Pulse System will be able to stop using the device due to sustained improvement in their condition as a result of the therapy.
For more information: www.hfclinicalstudy.com/index.htm