CircuLite Reports Preliminary Results of First-In-Man Pilot Study for SYNERGY™ Circulatory Assist Device
- SYNERGY™ Clearly Improves Quality of Life in Pilot Study Patients -
Hackensack, N.J. and AACHEN, Germany (February 21, 2008) - CircuLite™, Inc. today announced preliminary top-line results of a pilot first-in-man study of four patients that have been implanted with the SYNERGY™ Pocket Circulatory Assist Device. SYNERGY is 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. 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."
"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 two 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."
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.
The SYNERGY Pocket Circulatory Assist device is a small implantable blood pump designed to provide long-term, partial circulatory assist to patients with chronic heart failure. The key component of the SYNERGY device is the proprietary and patented micro-pump technology acquired after eight 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 is developing a miniature blood pump, designed to be placed superficially, for the long-term treatment of chronic heart failure. By providing long-term circulatory assist on a minimally invasive platform, CircuLite's SYNERGY has the potential to transform the management of chronic heart failure and improve the quality of life for millions of patients and their families. For more information on CircuLite and the SYNERGY Pocket Circulatory Assist device, visit our website at www.CircuLite.net.
MacDougall Biomedical Communications
Gail Farnan, Vice President, Marketing
CAUTION: Investigational Device. Limited by Federal Law to Investigational Use Only.
CircuLite® is a registered trademark of CircuLite, Inc. in the United States. SYNERGY™ is a trademark of CircuLite, Inc. in the United States.