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SPAS System is focused on the development and commercialization of a stent positioning assistance system (SPAS) for safer and faster percutaneous coronary intervention (PCI) procedures.
SPAS is a torque-like accessory that allows accurate, mm-precise stent positioning, minimizing and potentially eliminating geographical misses. It also enables stent manipulation and placement without impairment of the PCI workflow; more confident performance by less experienced ICs; and a shorter procedural time for complex PCIs.
SPAS is a class 2a device that is preloaded onto a stent delivery system. It has been validated on-bench, in silico, as the angio system for Simbionix, and in multiple clinical settings by industry leaders in Europe, Israel, and Russia.
A 55-patient first-in-human multicenter clinical study conducted in Israel returned no device-related adverse events. All five investigators stated that SPAS improved their ability to control stent deployment and achieve better accuracy in its positioning. The overall mean operator SPAS accuracy and satisfaction scores were also very high.