EDEN PRAIRIE, Minn., Jan. 05, 2016 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) today announced the appointment of Eric Lovett Ph.D., to the position of Vice President, Clinical Affairs. In this capacity, Dr. Lovett will manage the Company’s U.S. pivotal study (COUNTER HF™) for its flagship C-Pulse® Heart Assist System, a medical device designed to treat patients with moderate to severe heart failure.
“Eric brings to the Company a broad range of experiences in new ventures as well as large companies. Having led organizations from discovery through clinical evaluation and product launch, Eric’s broad experience is extremely valuable to an emerging company such as Sunshine Heart,” said John Erb, Chairman and Interim Chief Executive Officer of Sunshine Heart.
Dr. Lovett has been involved in the design, execution and administration of clinical studies for over 25 years. Prior to joining Sunshine Heart, Dr. Lovett was Vice President of Research and Innovation at CVRx, Inc. where he spent the last eight years. CVRx, Inc. is a privately held company working on implantable technology for the treatment of hypertension and heart failure. Prior to CVRx, Dr. Lovett worked for eight years at Guidant Corporation (later Boston Scientific, Inc.), leading research efforts on the development of cardiac rhythm management devices with emphasis on the treatment of heart failure. Dr. Lovett holds a Ph.D. in Biomedical Engineering from Marquette University and completed a postdoctoral fellowship studying cardiovascular effects of the autonomic nervous system at Harvard’s T.H. Chan School of Public Health and the Institute for Prevention of Cardiovascular Disease at the Beth Israel Deaconess Medical Center in Boston.
About the COUNTER HF Study
COUNTER HF is a prospective, randomized, multi-center clinical study. It is being conducted by heart failure and cardiac surgeon specialists in the United States. It is expected to randomize 388 patients in up to 40 clinical sites. The purpose of the study is to determine whether the C-Pulse System is a safe and effective treatment for heart failure patients who meet the following key study qualifications:
- NYHA Class III or early Class IV heart failure*;
- Ejection fraction ≤ 35% (measure of how well the heart pumps blood);
- Taking appropriate heart failure medications as prescribed by doctor; and
- Have been evaluated for cardiac resynchronization therapy with or without defibrillation (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) therapy.
*New York Heart Class (NYHA) Class III or early Class IV: Very limited in daily activities or unable to do activities without discomfort. Become tired, short of breath, and have heart palpitations during physical activity. Note: Other qualifications apply and study doctors will determine who is eligible for the study.
About the C-Pulse® Heart Assist System
The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient's current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.
Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.
About Sunshine® Heart
Sunshine Heart, Inc. (Nasdaq:SSH) is an early-stage medical device company focused on developing, manufacturing and commercializing the C-Pulse System for treatment of Class III and ambulatory Class IV heart failure. Sunshine Heart has completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical study of the C-Pulse System and presented the results in November 2011. In March 2012, the FDA notified the Company that it could move forward with an investigational device exemption (IDE) application. Sunshine Heart received unconditional approval from the FDA in November 2012 to initiate its pivotal study. In July 2012, Sunshine Heart received CE Mark approval for its C-Pulse System in Europe. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia and Ireland. The Company has been listed on the NASDAQ Capital Market since February 2012.