FFRangio for PCI assessment gets US FDA clearanceFebruary 4, 2019
FFRangio System, a non-invasive device for use during percutaneous coronary intervention (PCI) assessment, received approval in the US.
The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial equivalence of the FFRangio system.
The CathWorks FFRangio System quickly and precisely delivers the objective FFR guidance needed to optimize PCI therapy decisions, said Cathworks in a press release.
FFRangio is derived from routine X-rays acquired during a diagnostic angiogram procedure, is non-invasive and performed intra-procedurally during coronary angiography, eliminating additional clinical risk, time and cost associated with invasive FFR.
FFRangio provides a 3D reconstruction of the entire coronary tree with FFR values along each vessel.