March 7, 2008 – CircuLite has advanced its Synergy Pocket Circulatory Assist Device clinical program into a 20-patient trial, after completion of a first-in-man pilot study of Synergy in four patients, as the company seeks CE Mark approval in the European Union for long-term implantation of Synergy in heart failure patients.
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 engineered to provide long-term, partial circulatory support in patients with chronic heart failure.
The European registration trial is planned to enroll 20 patients with chronic heart failure and will evaluate the safety and patient quality of life improvements associated with device support of greater than six months. To-date, seven patients have been successfully implanted with the Synergy device. Six implants were performed by Bart Meyns, M.D., Ph.D., at Gasthuisberg University Hospital in Leuven, Belgium, the site of the first-in-man trial. One patient in the trial was implanted at Hannover Medical School in Hannover, Germany, by André Simon, M.D., managing doctor of the Thoracic Transplant Program, and Martin Strüber, M.D., director of the Thoracic Transplant Program. A third trial site, University Hospital in Münster, Germany, has completed training and is now screening patients for the CE Mark trial.
“We are pleased to have two new, highly respected European trial sites and surgical teams on board for Synergy’s clinical program,” commented Southworth. “The addition of these sites highlights the interest in, and need for, this type of device.”
CircuLite recently reported positive results from the European first-in-man pilot study, for which enrollment is now complete. Four patients were implanted with Synergy in this trial. These patients reportedly benefited from improvements in hemodynamics and were allowed to return to activities of daily living. All patients were said to have reached the primary endpoint of successful heart transplantation, with one patient supported for seven months.
For more information: www.CircuLite.net