CircuLite has accelerated its Synergy Pocket Circulatory Assist Device clinical program into a 20-patient trial designed to lead to CE Mark approval in the European Union for long-term implantation of Synergy in heart failure patients.
Synergy is a micro-implantable blood pump 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, according to the Hackensack, N.J.-based CircuLite.
“As a result of the success of our first-in-man pilot trial, we have embarked on this European approval trial for the long-term use of Synergy,” said Paul Southworth, president and CEO of CircuLite.
The European registration trial plans 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, according to the company. To-date, seven patients have been successfully implanted with the Synergy device; and six of those implants were performed by Bart Meyns, MD, PhD, at Gasthuisberg University Hospital in Leuven, Belgium, the site of the first-in-man trial.
CircuLite recently reported positive results from the European first-in-man pilot study. Four patients were implanted with Synergy in this trial.