Saint Luke's becomes first center in the region to implant novel heart assist device
KANSAS CITY, Mo. — Saint Luke's Mid America Heart Institute performed the first successful implant in the region of the C-pulse heart assist device on July 21. The patient was the tenth in the nation to receive the device as part of a 20-person clinical trial approved by the U.S. Food and Drug Administration (FDA). Saint Luke's is the only heart center in the region participating in the trial.
“We are very proud to be a part of this innovative clinical trial,” said cardiothoracic surgeon Sanjeev Aggarwal, M.D., director of Mechanical Circulatory Support at Saint Luke's Mid America Heart Institute. “The C-pulse device may represent an important advance in the treatment of patients suffering from advanced heart failure. It can be implanted utilizing a minimally invasive surgical procedure, without the need for anticoagulation (blood thinners).”
The clinical effects of the device in the initial patient implant were dramatic, said Dr. Aggarwal. “The patient experienced an immediate improvement in heart function and an improvement in breathing and activity level within the early post-operative period. This technology has the potential to benefit a large number of patients suffering from heart failure.”
The C-pulse system, developed by Sunshine Heart, Inc., is implanted as a cuff around the ascending aorta. The cuff inflates and deflates, providing counterpulsation similar to an intra-aortic balloon pump. The device is able to reduce the workload of the heart as well as increase blood flow to the heart muscle. Because the device does not come into direct contact with the patient's bloodstream, it does not require blood-thinning medications and can be turned on and off without the risk of clot formation.
The study is conducted at Saint Luke's under the direction of Dr. Aggarwal, cardiothoracic surgeon Michael Borkon, M.D., and cardiologist Andrew Kao, M.D.
About Heart Failure
Heart failure makes the heart weak or stiff, leaving it unable to pump normally or supply enough blood to meet the body's needs. Heart failure patients usually experience shortness of breath, low blood pressure, extra fluid and cannot exercise. The American Heart Association (AHA) estimates that about five million Americans are affected by congestive heart failure, with 600,000 new cases diagnosed each year. The prognosis for patients with advanced heart failure is poor, with projected one-year mortality rates exceeding those of other terminal diseases such as AIDS, leukemia and lung cancer. According to the AHA, cardiovascular disease remains the No. 1 cause of death in the United States.
About Saint Luke's Heart Failure and Transplantation Program
Saint Luke's Heart Failure and Transplant Program is an integrated program offering comprehensive services to patients with all stages of heart failure, including mechanical circulatory support and heart transplantation. Now celebrating the 25th year of its founding, the heart transplant program has grown to become one of the top 10 in the nation, surpassing national benchmarks for volumes and survival in adult cardiac transplantation. The program has transplanted more than 462 patients since 1985.
About Sunshine Heart
Sunshine Heart (ASX: SHC) (www.sunshineheart.com) is a global medical device company, committed to the commercialization of C-Pulse™, an implantable, non-blood contacting, heart assist therapy for the treatment of people with moderate heart failure. The trial is being conducted to determine the effectiveness of C-Pulse in reducing symptoms of heart failure through the use of counterpulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and reduction in the heart's pumping load. The Company has received approval from the U.S. Food and Drug Administration (FDA) to conduct a 20-person U.S. clinical trial with C-Pulse and patient enrollment has commenced. Sunshine Heart, listed on the ASX in September 2004, has a presence in Australia, New Zealand and the USA.
For further information, please visit www.sunshineheart.com.