EDEN PRAIRIE, Minn., June 18, 2013 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) today announced a major milestone for its flagship C-Pulse device. As of today, C-Pulse has been implanted in 25 patients in North America and Germany, representing a cumulative 25 years of active C-Pulse heart failure treatment, or over one billion inflation and deflation cycles. The 25 th patient was implanted on June 14, 2013 at German Heart Institute – Berlin (DHZB).
Of particular note, throughout decades of treatment, C-Pulse has never recorded a neurologic event associated with the device, most commonly defined as a stroke or transient ischemic attack (TIA). This neurological safety profile represents a potential unique advantage of C-Pulse as the device does not contact the blood stream nor require blood thinning agents. To date, no other known cardiovascular blood contacting mechanical support devices have shown these results in a published pilot or pivotal clinical trial.
The Company has recently reported an additional two patients have been targeted for weaning from the technology in addition to two previously weaned patients that were permanently disconnected from the device based upon improvement in their heart failure symptoms.C-Pulse is designed to treat Class III and ambulatory Class IV heart failure. The device utilizes proven balloon counterpulsation technology to assist the heart by reducing the workload of the left ventricle. The device may be implanted via a minimally invasive surgical procedure, which is generally performed in an hour. A pre-sutured cuff is placed around the ascending aorta, outside the patient's bloodstream. This strategic placement of the device is a likely contributor to the neurologic safety profile relative to competitive devices, reducing the risk of stroke incidence and blood clotting. Additional advantages of the device include a durable cuff, with zero cuff failures being recorded in the North American feasibility and European post-market trials; as well as the ability of patients to seamlessly disconnect (and re-connect) from the device based on symptom improvement, further enhancing patients' quality of life.