For those people suffering from cardiomyopathy, or any form of moderate heart failure, there may soon be a device able to take over some of the hard work their hearts are put through.
Cardiologists believe the new C-Pulse will benefit patients with class III heart failure – classified by limitations of physical activity. Patients with this type of heart failure experience extreme tiredness, shortness of breath, low blood pressure and dizziness and have few options other than open-heart surgery, or a heart transplant.
Device makers Australian Sunshine Heart Company and Ohio State University are currently conducting a 20 patient, U.S. Food and Drug Administration-approved clinical trial in the United States.
Over 1.4 million people in the United States a year suffer from class III moderate heart failure.
Cardiomyopathy is a disease of the heart muscle in which the heart isn't able to function efficiently and pump blood adequately throughout the body. The implanted C-Pulse device is able to increase cardiac output and generate a greater blood flow, thereby reducing the strain on the heart to pump. The C-pulse is able to increase the flow of blood to the heart muscle by 65 percent.
The device comes in three parts: a cuff, consisting of a wrap and balloon, a sensor lead and a base unit worn outside of the body on a belt.
The surgery to implant the C-Pulse is done under general anesthetic and would normally take about two hours. The cuff is wrapped around the aorta in the chest, above the heart. The sensor lead is inserted into the heart through a vein. The lead and cuff is attached to a wire and comes out under the skin and exists in the abdomen, attached to a controller. The entire device is powered by rechargeable batteries and can be turned on and off, when required, by the patient themselves.
As the heart fills with blood a small balloon, located inside the cuff, inflates forcing blood through the aorta to the rest of the body, distributing blood more efficiently.
The device functions without any contact to blood, lessening any complications or infections for the patient.
“C-Pulse is highly innovative and implanted with a simple, low-risk, minimally invasive procedure. The device has the potential to offer a new therapy option for the treatment of moderate heart failure,” said Dr. Benjamin Sun, chief of the Division of Cardiothoracic Surgery and director of the Cardiac Transplant and Medical Support.
“The start of our clinical trial brings us one step closer toward out goal to address the large and growing unmet clinical need for an alternative heart failure treatment to improve and sustain a patient's quality of life,” said Don Rohrbaugh, CEO of Sunshine Heart Company.
Source: http://www.sunshineheart.com/pdfs/Sunshine_Heart_First.pdf