The FFRangio System enables non-invasive, objective functional evaluation of multi-vessel coronary artery disease and receives FDA clearance.- CathWorks

CathWorks announced that its FFRangio System received FDA 510(k) clearance. 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. 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.

Comment: Fractional flow reserve (FFR) is a measurement of the blood pressure before and after a narrowing of an artery. The larger the difference in the pressure across the stenosis, the more need there is to perform an interventional procedure to open up the artery. Normally, FFR is measured using a special intravascular catheter and this is now quite common. Nevertheless, traditional FFR involves its own procedural risks, takes a good deal of time to perform, and adds substantial costs. FFRangio system is a non-invasive alternative to traditional FFR.