CircuLite has received approval from Federal Agency for Medicines and Health Products in Belgium to commence the CE mark trial of the Synergy IC circulatory support system, the first mechanical support system that does not require major surgery. The system is based on the surgical Synergy circulatory support system, the worldâs smallest commercially available circulatory support pump designed to treat ambulatory chronic heart failure patients (Intermacs >=4).
While the Synergy IC circulatory support system uses the same superficially placed micropump platform as the surgical system, it is the first implantable circulatory support system whose inflow cannula is designed to be implanted by a cardiologist using standard interventional techniques. The procedure is designed to further reduce the invasiveness of implantation, and thereby reduce the rate and severity of adverse events.
The multi-centre CE mark trial will enrol up to 20 patients, starting in Belgium and expanding to two additional European clinical sites. Clinical status, end organ function, exercise tolerance, functional capacity and quality of life will be assessed post-implantation. Patient screening has commenced at the University Hospitals Leuven, Belgium.
The surgical Synergy system received CE mark in September 2012 and is commercially available in Europe.