CircuLite has received an approval from the Federal Agency for Medicines and Health Products to begin the CE Mark trial of the Synergy IC Circulatory Support System (SICSS), which is designed for interventional cardiologist cannula deployment.
Based on the surgical Synergy Circulatory Support System, the SICSS uses superficially placed micro-pump platform as the surgical system and is designed to further minimise the invasiveness of implantation, reducing the rate and severity of adverse events.
CircuLite Chief Medical Officer Daniel Burkhoff said, "If successful, this approach will usher in a new era in mechanical circulatory support, much the same way TAVR did for aortic valve replacement."
The multi-center CE Mark trial will enroll up to 20 patients, beginning in Belgium and expanding to two additional clinical locations in Europe.
The post-implantation assessment includes clinical status, end organ function, exercise tolerance, functional capacity and quality of life.
CircuLite CEO Paul Southworth said, "With an even less invasive, interventional procedure performed in the cath lab or hybrid OR, we will be making the SYNERGY system more accessible, more convenient and potentially safer for patients."