By
Sunshine Heart Inc
Design + Industry Pty Ltd
Hydrix Services Pty Ltd
Description
The C-Pulse® Heart Assist System is an implantable extra-aortic balloon pump using counterpulsation technology to treat moderate to severe heart failure (Class III and Class IV ambulatory). It is placed outside the bloodstream, can be performed minimally invasively, and can be disconnected. It is designed to improve heart function by, increasing coronary blood flow, decreasing afterload and increasing cardiac output. C-Pulse consists of a polyurethane balloon and polyester wrap fitted to conform to the ascending aorta. As the balloon inflates in increases coronary flow and cardiac function. When the cuff deflates it creates negative pressure in the aorta decreasing afterload.
Key Features
and/or Benefits
C-Pulse System patients are suffering from class III or ambulatory class IV heart failure and have a significantly decrease quality of life. They currently on optimal medica therapy, most likely have a implantable defibrillator or cardiac resynchronization therapy deice yet continue to have worsening heart failure.Their daily lives have becasome severely liite to the point where they have difficulty aiior are unable to drive, work, or perform normal daily activities without becoming tired, short of breath, or having heart palpitations. The C-Pulse system is designed to provide relief from these symptoms by providing providing more oxygen-rich blood to the heart.
Heart failure is a progressive disease.Current practice is to maintain optimal therapy until the patient progresses to the next stage of heart failure, when aggressive treatments such as heart transplants are considered. There are no other current solutions for C-Pulse candidates, and no known competitive technology outside of the bloodstream. The C-Pulse System provides these patients with an option for a device designed to increase their mobility and quality of life, and is designed to halt the progression of the disease. By keeping these patients out of hospital C-Pulse potentially reduces the largest health care expense in the US: re-hospitalization.
The C-Pulse Cuffis implanted via a small pacemaker like incision through the ribs and sternum.There are no incisions made to the heart itself or any major vessels. The heart is beating during the surgery and a heart-lung bypass machine is not necessary. Several patients have been able to return home in as little as four days when the procedure has been performed minimally invasively.
Because the C-Pulse Cuff does not contact the bloodstream the risk of stroke and blood clots is potentially reduced. There is no need for patients to take anti-clotting medications such as heparin or warfarin while implanted. Because of these features, the procedural and device risks to patients may be lower when compared to other currently approved mechanical circulatory assist technologies. Patients can safely disconnect the Driver to have intervals of freedom to perform certain activities such as showering.
The Cuff connects to a pneumatic/electrical line terminating at the abdomen. This plugs into an externally worn Driver housed in a durable carry bag, that protects the device from water ingress and wear and tear. The Driver contains sophisticated electronics, sensing the heart’s electrical signals via ECG and inflating and deflating the cuff in rhythm with the heart. All parts are selected to minimise carrying weight light lithium ion smart battery and a custom aluminium pump. Careful layout of components produced the most compact device possible, whilst simplifying interaction and meeting stringent criteria for thermal and mechanical performance.
