Sunshine Heart Appoints VP of Clinical Affairs

Eden Prairie, Minn.-based Sunshine Heart Inc. has named Eric Lovett, Ph.D., to the position of vice president, clinical affairs. In this capacity, 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,” said John Erb, chairman and interim CEO of Sunshine Heart. “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.”

Lovett has been involved in the design, execution and administration of clinical studies for over 25 years. Prior to joining Sunshine Heart, Lovett was vice president of research and innovation at CVRx Inc. where he spent the last eight years. CVRx is a privately held company working on implantable technology for the treatment of hypertension and heart failure. Prior to CVRx, 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. 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 University’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, Mass.

Counter HF is a prospective, randomized, multi-center clinical study 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 certain key study qualifications.

The C-Pulse heart assist system, or C-Pulse system, is an investigational device in the United States, Canada and countries that do not recognize the CE mark approval. It uses 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 Sunshine Heart’s feasibility study, the company believes that some patients treated with the system may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.