CircuLite has received CE Mark approval for the Synergy circulatory support system, a micro-pump designed to halt the progression of heart failure (HF).
By working with the heart’s natural pumping capacity, Synergy is targeted for treatment of ambulatory HF patients (INTERMACS 4,5,6 / NYHA IIIB and early IV) who remain symptomatic despite standard medical management, according to the Aachen, Germany-based company.
Synergy is approximately the size of a AA battery and is implanted superficially in a pacemaker-like pocket under the right collarbone, the company said in a release. Unlike ventricular assist devices, implantation does not require an open-chest procedure or cardiopulmonary bypass.
CE Marking approval was based on positive clinical results from 44 patients in an ongoing, multicenter European trial that was recently presented at the International Society for Heart and Lung Transplantation (ISHLT) meeting. A total of 59 patients have been implanted with the Synergy system in the CE Mark trial at nine European centers.
The Synergy circulatory support system is a micro-blood pump that provides up to 4.25 liters of blood per minute, according to CircuLite.