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Saint Luke's Mid America Heart and Vascular Institute in Kansas City Successfully Implants Innovative Heart Failure Therapy through a Small Incision - Minneapolis, MN 

Sunshine Heart Inc., a global medical device company focused on innovative technologies for moderate heart failure, today announced that its C-Pulse® Heart Assist System has been successfully implanted using a minimally invasive thoracotomy procedure at Saint Luke's Mid America Heart and Vascular Institute in Kansas City, MO. 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.

“We are pleased to welcome Saint Luke's Mid America Heart and Vascular Institute to our C-Pulse clinical trial,” said Dave Rosa, CEO of Sunshine Heart. “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.”

Sanjeev Aggarwal, MD, Director of Mechanical Circulatory Support at Saint Luke's Mid America Heart and Vascular Institute in Kansas City, Missouri, performed the procedures. In addition to performing the first minimally invasive thoracotomy C-Pulse procedures, Dr. Aggarwal has also successfully performed a minimally invasive hemi-sternotomy (mini-sternotomy) C-Pulse procedure at St. Luke’s Hospital. “The C-Pulse Heart Assist System represents an important advance in the treatment of patients suffering from heart failure,” commented Dr. Aggarwal. “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.“