CircuLite has advanced its Synergy Pocket Circulatory Assist Device clinical program into a 20-patient trial designed to lead to CE Mark approval in the EU for long-term implantation of Synergy in heart failure patients.
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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. The company also announced that a third trial site, University Hospital in Munster, Germany, has completed training and is now screening patients for the CE Mark trial.
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.
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