CE Mark for SYNERGY circulatory support system

SADDLE BROOK, NJ, USA & AACHEN, GERMANY – A micro-pump designed to halt the progression of heart failure, SYNERGY? Circulatory Support System, has received CE marking approval, announced the device maker CircuLite.

SYNERGY is targeted for treatment of ambulatory heart failure patients (INTERMACS 4,5,6 / NYHA IIIB and early IV) who remain symptomatic despite standard medical management. The device gained CE Marking approval based on positive clinical results from 44 patients in an ongoing, multi-center trial in Europe, which was recently presented at the International Society for Heart and Lung Transplantation (ISHLT) meeting. The SYNERGY System has currently been implanted in 59 patients in the CE Mark trial at 9 European centres.

The  device is about the size of an AA battery. It is implanted superficially in a pacemaker-like pocket under the right collarbone. The device is around 90 percent lighter than existing ventricular assist devices (VADs). Unlike VADs, the implantation of SYNERGY does not require an open-chest procedure or cardiopulmonary bypass.

"There is currently a gap in the treatment of heart failure, with no satisfactory options available for patients who are not responding to standard medical therapy. SYNERGY, with its small size, minimally invasive procedure and relatively fast procedure time, is ideally suited for these patients," said Bart Meyns, M.D., Ph.D., professor and chief of Cardiac Surgery at Gasthuisberg University Hospital and principal investigator of CircuLite's clinical study.

"In my experience with this technology, the results have been remarkable. Patients typically recover from the procedure quickly and are soon after able to perform many activities that they could not do before. This technology allows me to provide a new treatment strategy for a large number of patients who previously had no definitive options," Dr Meyns said.

The European approval of SYNERGY is a significant milestone both for CircuLite and, more broadly, for the treatment of heart failure, said company president and chief executive officer Paul Southworth.

"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. With CE Marking in place, we will begin a controlled launch of this groundbreaking advancement in select European markets," Mr Southworth said.