CircuLite (Saddle Brook, NJ) won EU clearance for its SYNERGY mini blood pump, a device the size of a AA battery that’s implanted without a bypass or even a open-chest procedure. The pump provides 4.25 liters of blood flow per minute and is positioned superficially similarly to a pacemaker.
The pump features a sealed brushless motor, as well as a self-washing flow path and smart control algorithms, all designed to prevent thrombus formation.
From the product page:
CE Marking approval was based on positive clinical results from 44 patients in an ongoing, multi-center 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 centers.
“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.”
Press release: CIRCULITE® RECEIVES CE MARKING APPROVAL FOR SYNERGY® CIRCULATORY SUPPORT SYSTEM
Product page: SYNERGY…
Flashbacks: Synergy Pocket Circulatory Assist Device Does Well in Early Trial; First Implantation of Circulite’s Synergy Mini Blood Pump
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