Sunshine Heart Story
Sunshine Heart is a global medical device company founded by a cardiac surgeon that saw an incredible opportunity for how to treat heart failure. Heart failure (HF) affects millions and is a progressive condition that prevents patients from living normal lives. Sunshine Heart’s C-Pulse® Heart Assist System has CE Mark in Europe and is in a clinical study in the United States to determine if the C-Pulse System is safe and effective for treating moderate to severe heart failure. C-Pulse therapy is designed to reduce overall heart failure symptoms, improve quality of life, and reduce re-hospitalizations.
Sunshine Heart’s C-Pulse® Heart Assist System is an innovative approach to assist the heart’s function, not replace it, and may be implanted using a minimally invasive surgical approach. The C-Pulse Heart Assist System is designed to treat clinical symptoms associated with Class III and ambulatory Class IV heart failure, sometimes also referred to as moderate and severe failure. Patients associated with Class III and ambulatory Class IV heart failure are typically unable to engage in normal activities, compromising their quality of life.
The C-Pulse System leverages the concept of balloon counterpulsation technology to assist the heart by reducing the workload of the left ventricle. During inflation of the balloon, blood flow is increased to the coronary arteries, thereby providing additional oxygen which is vital to a failing heart. During deflation, the workload, or pumping required by the left heart is reduced. The balloon inflation and deflation is synchronized to the patient’s natural heartbeat via ECG sensing lead.
Potential benefits of the technology include increased cardiac function, enhanced mobility and improved quality of life. Physicians have commented that patients experience symptomatic relief almost immediately after device placement.
Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse Heart Assist System.
Sunshine Heart received approval from the FDA to initiate its pivotal study. The purpose of the study is to determine whether the use of the C-Pulse as a treatment for patients with moderate to severe heart failure demonstrates safety and efficacy. If successful, Sunshine Heart will work with the Food and Drug Administration (FDA) to obtain approval to market the device in the United States.
The primary study population will include 388 subjects randomized in up to 40 centers in the United States (US). The treatment group will include 194 subjects implanted with the C-Pulse System in comparison to 194 subjects treated with optimal medical therapy alone.
To learn more about the COUNTER HF™ Clinical Study, please visit: hfclinicalstudy.com