CathWorks’ FFRangio System Granted FDA 501(k) Clearance
December 21, 2018—CathWorks announced it has received FDA 510(k) clearance for their FFRangio system. According to the company, the FFRangio system delivers quick and precise fractional flow reserve (FFR) guidance to help optimize decision-making during percutaneous coronary intervention therapy.
The FDA approval comes after data reported from the pivotal, blinded FAST-FFR comparative study that evaluated the FFRangio system versus an invasive FFR wire. According to the company, FAST-FFR confirmed the accuracy of FFRangio system and established substantial equivalence of the system.
CathWorks explained in their announcement that FAST-FFR showed the clinical predictive value across a full range of coronary physiology, including complex lesion assessment in bifurcations and calcified lesions. The FAST-FFR study evaluated more than 380 patients at 10 centers around the world.
FFRangio is derived from routine x-rays acquired during a diagnostic angiography. The process is noninvasive and performed intraprocedurally during coronary angiography, which eliminates additional clinical risk, time, and cost associated with invasive FFR. FFRangio provides a three-dimensional reconstruction of the entire coronary tree with FFR values along each vessel, explained CathWorks in their press release.