February 27, 2008 - CircuLite Inc. released preliminary results of a pilot first-in-man study of four patients who have been implanted with the Synergy Pocket Circulatory Assist Device, a micro implantable blood pump, the size of a AA battery, that can be implanted superficially in a “pacemaker-like” pocket.
The device is designed to provide long-term, partial circulatory support in patients with chronic heart failure.
Four patients were enrolled in the pilot study, which was initiated in June 2007 and evaluated Synergy in individuals awaiting a heart transplant. All patients reached the primary endpoint of successful heart transplantation, with one patient supported for 7 months, said CicuLite. Final data from this study will be presented at a future medical meeting.
“Patients implanted with Synergy thus far have demonstrated significant clinical improvements in hemodynamics and, importantly, quality of life,” said Bart Meyns, M.D., Ph.D., professor and chief of cardiac surgery at Gasthuisberg University Hospital (Katholieke Universiteit) in Leuven, Belgium. “This system was designed to improve the quality of life of chronic heart failure patients by giving them a less invasive option to increase blood flow from the heart, so we are encouraged to see that initial patient experiences have been consistent with this goal.”
The pilot study cohort will be included in CircuLite’s 20-patient long-term support CE Mark trial that is currently enrolling patients. The CE Mark trial is designed to support a CE Mark filing at the end of 2008, said the company.
For more information: www.CircuLite.net