The Synergy Pocket Circulatory Assist (PCA) device is a small, implantable blood pump (size of a AA battery) designed to provide long-term, partial circulatory assist to patients with chronic heart failure. The key component of the Synergy device is the micro-pump technology acquired after 8 years of development at the Helmholtz Institute in Aachen, Germany, one of the world’s leading centers for blood pump technology development, in collaboration with Katholieke Universiteit in Leuven, Belgium. The device is small enough to be implanted subcutaneously in a “pacemaker-like” pocket through a minimally invasive procedure. Synergy is designed to supplement the heart’s native pumping function, potentially increasing blood flow and allowing the heart to rest and potentially recover, possibly improving the quality of life of chronic heart failure patients.
CircuLite, Inc., developer of Synergy, announced preliminary top-line results of a pilot first-in-man study of patients that have been implanted with the Synergy PCA device. 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.
“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.”
“Having completed enrollment in our short-term pilot study, we are now focused on evaluating Synergy for long-term use in patients who remain symptomatic despite optimal medical management, but may also not be sick enough to be eligible for one of the very few donor hearts available each year,” commented Paul Southworth, President and CEO of CircuLite. “This large, underserved population of over 2 million patients is the ultimate target for our device. We believe that long-term, partial circulatory assist represents a new and promising treatment approach to chronic heart failure that may better address these patients, and we are excited by the significant impact on hemodynamics and quality of life experienced in the pilot study patients.”
CircuLite Press Release (02/21/08)
Technology Review (05/08/08)
CircuLite Synergy Pocket Circulatory Assist Device