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Devices Cardiology

 News Release - October 26, 2010

St. Paul Heart Clinic First in Upper Midwest to Implant New Early-Stage Heart Failure Device

Two Patients Successfully Treated With the C-Pulse(R) Heart Assist System From Eden Prairie-Based Sunshine Heart

ST PAUL, MN--(Healthcare Sales & Marketing Network) - St. Paul Heart Clinic announced today that the first patients in Minnesota have been implanted with the world's first known non-blood contacting mechanical heart assist system designed to help reverse the heart failure process for people with Class III/IV ambulatory heart failure. The C-Pulse Heart Assist System, developed by Eden Prairie-based Sunshine Heart, was implanted in two patients at the Nasseff Heart Hospital in St. Paul as part of an FDA-approved IDE feasibility study.

When patients are first diagnosed with (Class I & II) mild heart failure, the first lines of treatment include lifestyle changes and drug therapy. If the disease progresses to moderate (Class III) heart failure, cardiologists often recommend implantation of a biventricular pace maker, an implantable cardioverter-defibrillator (ICD), or both. Following these treatments, however, there are few, if any, FDA-approved therapies until the disease progresses to advanced Class IV (severe) heart failure. This stage requires more complicated interventions, such as left ventricular assist devices (LVAD), which take over the pumping function of the heart; or ultimately, heart transplants.

"A primary focus at St. Paul Heart Clinic is to address and stabilize heart failure at its earliest possible stages, before patients require later stage LVADs or heart transplants," said Dr. Alan Bank, M.D., Cardiologist and Medical Director of the Research Division at St. Paul Heart Clinic.

The C-Pulse heart assist system is implanted during open heart surgery by placing a cuff around the aorta as it exits from the heart. This unique balloon counterpulsation technology 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 LVADs or transplants. The C-Pulse System is one of just a few devices under investigation that may help alleviate heart failure symptoms and prevent the disease from advancing to a condition in which an LVAD or transplant is needed.

To date, Dr. Bank and Dr. John Grehan, Cardiovascular Surgeon at Nasseff Heart Hospital, have treated two Class III heart failure patients with the C-Pulse Heart Assist System: a 70-year-old male from Stillwater who was implanted with the device on September 24th, and a 64-year-old male patient from Faribault who was implanted on October 5th. The patients were just the 14th and 15th respectively in the United States implanted with C-Pulse, and the 20th and 21st in the world to receive this therapy. Both were discharged from the hospital within 8 days and have reported a reduction of shortness of breath and an increase in activity during their recovery. "I am impressed with the immediate effects provided by the C-Pulse and I look forward to seeing how patients improve over time," added Dr. Bank.

St. Paul Heart Clinic is currently the only non-LVAD and transplant cardiology practice in the country with access to this technology that is participating in the C-Pulse IDE feasibility study. The study, which is expected to conclude later this fall, is available to men and women between the ages of 18 to 75 who suffer from moderate heart failure and for whom standard drug therapy has failed. The study will monitor each patient's performance with the C-Pulse System at one-month, three-month and six-months following implantation.

"St. Paul Heart Clinic is an ideal cardiology practice to participate in the feasibility of the C-Pulse system," said Dave Rosa, CEO of Sunshine Heart. "C-Pulse presents the opportunity for non-LVAD/transplant centers to potentially offer a therapy for Class III and Class IV ambulatory patients."

If you or someone you know is interested in participating in the C-Pulse clinical trials, please contact Glenda Morris, APRN at gmorris@stphc.com or (651) 726-6967. To learn more about Sunshine Heart's FDA-approved IDE feasibility study, please visit www.clinicaltrials.gov.

About St. Paul Heart Clinic

St. Paul Heart Clinic is one of the largest, most advanced heart clinics in the region, serving patients throughout Minnesota and western Wisconsin. The clinic's 31 cardiologists work in close partnership with primary care physicians to provide comprehensive cardiovascular care to their patients. The clinic's subspecialties of heart care include noninvasive cardiology, interventional cardiology, electrophysiology, advanced imaging and research. For more information, please visit: www.stphc.com.

About United Hospital

United Hospital, part of Allina Hospitals & Clinics, is the largest hospital in the Twin Cities east metro area. It is a non-profit hospital providing a full range of health care services to more than 200,000 people each year. United offers a wide range of health services including a birth center, cardiac care in the Nasseff Heart Center, emergency care, oncology, orthopedics, neurosciences and epilepsy, a pain center, rehabilitation, medical imaging and surgery. More information about United Hospital can be found at www.unitedhospital.com.

About Sunshine Heart®

Sunshine Heart® (ASX:SHC ), a global medical device company focused on innovative technologies for the treatment of moderate heart failure, is commercializing the C-Pulse® Heart Assist System, a minimally invasive, implantable, non-blood contacting, heart assist therapy for the treatment of moderate heart failure. The Company has received approval from the US Food and Drug Administration (FDA) to conduct a 20-patient U.S. clinical trial with the C-Pulse® System and the study has achieved eighty percent enrollment as of October 2010. Sunshine Heart is a Delaware-based Corporation headquartered in Minneapolis with a subsidiary presence in Australia. The Company has been listed on the ASX since September 2004. For more information, please visit www.sunshineheart.com.


Source: St. Paul Heart Clinic

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