CircuLite has obtained CE mark for its new micro-blood pump Synergy Circulatory Support system, designed to treat ambulatory heart failure patients (INTERMACS 4,5,6 / NYHA IIIB and early IV).
The Synergy system, which is implanted using a mini-thoracotomy, is placed in a pacemaker-like pocket under the right collarbone to deliver 4.25 liters of blood per minute and to reduce the heart’s workload, while improving blood flow to vital organs.
The CE mark approval was based on positive clinical results from 44 patients multi-center European trial, designed to demonstrate the safety and efficacy of Synergy system.
CircuLite president and chief executive officer Paul Southworth said Synergy changes the paradigm of heart failure treatment for those who are not responding to standard medical management by working as a complement to the heart’s function.
"The benefits are multifaceted — patients feel better, recover rapidly and are discharged quickly — which provides the potential for a cost reduction impact for hospitals," Southworth added.
"With CE Marking in place, we will begin a controlled launch of this groundbreaking advancement in select European markets."