Sunshine Heart  today SHC (ASX listed) announced that its C-Pulse Heart assist system has been successfully implanted using a minimally invasive thoracotomy procedure at a leading US hospital. 13 Patients have now received and implant in the worldwide C-Pulse study protocols. The C-Pulse System is the first known mechanical heart assist system to be implanted using a minimally invasive thoracotomy technique. The device was inserted through a small, pacemaker-like incision between the patient’s ribs, leaving the sternum intact. To date, thirteen patients have been implanted under Sunshine Heart’s existing worldwide C-Pulse study protocols. The FDA approved IDE feasibility study will include a total of 20 patients to evaluate the performance of this device for patients with moderate heart failure.

The C-Pulse Heart Assist System is designed to treat patients suffering from the debilitating effects of moderate heart failure caused by a failing left ventricle (the left heart chamber). The C-Pulse System features a unique balloon counterpulsation technology that is designed to assist the left ventricle by reducing the workload required to pump blood throughout the body. In addition, it increases blood flow to the coronary arteries. Combined, these potential benefits may help reverse the heart failure process or maintain the patient’s current condition, thereby preventing the need for later stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants.


Sunshine Heart Chief Executive Officer, Dave Rosa, said, “These latest procedures accomplish our goal of successfully implanting the C-Pulse System through a mini-thoracotomy surgical method. As we approach the end of our feasibility study, we are encouraged by the interest of our centers and we remain dedicated to developing this minimally invasive, cost-effective treatment that is intended to relieve the symptoms of moderate heart failure.”


The procedures took place at Saint Luke's Mid America Heart and Vascular Institute in Kansas City, Missouri, US, where Director of Mechanical Circulatory Support Dr. Sanjeev Aggarwal said, “The C-Pulse Heart Assist System represents an important advance in the treatment of patients suffering from heart failure. In our initial procedure last month, the clinical effects were dramatic, with an almost immediate improvement in cardiac performance and the patient’s functional status. I am very encouraged that we were able to perform our two subsequent implants utilizing a minimally invasive pacemaker-like incision, without dividing the sternum. This offers the opportunity to provide patients suffering from moderate heart failure with a means of mechanical circulatory support through a truly minimally invasive, low risk procedure with a short recovery period.“
The C-Pulse System is an earlier intervention than other mechanical therapies, such as LVADs. This device does not make direct contact with patient’s blood and it can be turned on or off at any time allowing patients intervals of freedom to perform certain activities. The C-Pulse System can also be implanted as a minimally invasive procedure, thereby potentially reducing procedural time, hospital stays, overall cost and patient risk as compared to a traditional sternotomy.


Sunshine Heart’s FDA approved IDE study is available to men and women between the ages of 18 to 75 who suffer from Class III/ ambulatory Class IVA heart failure and for whom standard drug therapy has failed. The study monitors each patient's performance with the C-Pulse System at one-month, three-month and six-month intervals to assess risks and potential benefits. Each patient’s physical endurance, quality of life and cardiac performance will also be specifically monitored.

Source: Sunshine Heart