On 5 September, CircuLite announced that it has received the CE mark approval for its Synergy Circulatory Support System, a micro-pump designed to halt the progression of heart failure.
By working with the heart’s native pumping capacity, Synergy is specifically targeted for treatment of ambulatory heart failure patients (INTERMACS 4,5,6 / NYHA IIIB and early IV) who remain symptomatic despite standard medical management.
Synergy is approximately the size of a AA battery and is implanted superficially in a pacemaker-like pocket under the right collarbone. According to CircuLite, the device is approximately 90% lighter than existing ventricular assist devices (VADs), and unlike VADs, implantation of Synergy is faster and 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, multicentre European trial, 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 9 European centres.
“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, 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.”
The Synergy system is limited to investigational use in the USA.