Sunshine Heart, a global medical device company, is the inventor of the C-Pulse Heart Assist System. C-Pulse Heart Assist System is said to have been designed to treat moderate heart failure in a patient, by boosting their cardiac output. Now, recently this company has announced that The Ohio State University Medical Center in Ohio has succeeded in completing its first two implants using this particular system in a clinical trial. This implant is said to have been approved by the FDA.
The C-Pulse Heart Assist System is believed to be a non-blood contacting, implantable counter-pulsation treatment. This system is stated to be a pliable, inflatable cuff which is enclosed around the aorta of the patient. By inflating and deflating with the patients heart beat, this system executes an action called the counter-pulsation. Through this methodology, the system apparently succeeds in increasing the flow of oxygenated blood to the heart, along with improving the blood flow to the heart muscles and body. It also aids in reducing the amount of pressure on the heart, thereby aiding the fragile heart to pump more blood.
As this system is placed outside the aorta, it avoids any contact with the heart. It is implanted, via an uncomplicated surgery which is conducted on a beating heart. This implantation supposedly does not require incisions to the heart or great vessels, or even heart-lung bypass.
The C-Pulse is said to utilize a soft percutaneous line, a standard pacemaker lead and an external pneumatic battery-operated Driver. More so, it was also that, for comfort or hygiene, this system could also be disconnected from the Driver, by the patient himself.
Dr. William Peters, Medical Director of Sunshine Heart and the inventor of C-Pulse, says that, “We are excited that our clinical trial in the U.S. has started so successfully. We have demonstrated in prior clinical studies that the C-Pulse system increases blood flow to the body and to the heart muscle itself. We anticipate that C-Pulse will offer patients a significant improvement in quality of life.â€
The doctor who successfully conducted these implants, Dr. Benjamin Sun, Chief, Division of Cardiothoracic Surgery and Director, Cardiac Transplantation and Mechanical Support, says that, “It is an honor to have completed the first U.S. implants of the C-Pulse heart assist system. C-Pulse is highly innovative and implanted with a simple, low-risk minimally invasive surgical procedure. The device has the potential to offer a new therapy option for the treatment of moderate heart failure.â€
The Company’s CEO, Don Rohrbaugh, says that the successful implantation of the C-Pulse in the U.S. could be a huge highlight for the Company. The commencement of a clinical trial for this System is stated to have gotten the Company closer to fulfilling the needs of the heart failure patients by enhancing and maintaining their quality of life. This System is said to have been especially designed for Class III heart failure patients, which would constitute of those patients who inspite of having received maximum drug therapy, seem to be suffering from continuing debilitating symptoms.