US FDA 510(k) clearance has been granted for the FFRangio System (CathWorks). 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 delivers FFR guidance to assist percutaneous coronary intervention (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, aiming to reduce 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.
Jim Corbett, CathWorks CEO said, “The FDA clearance of CathWorks FFRangio is a milestone for interventional cardiologists and the healthcare system overall. It is the first non-invasive device of its kind to receive FDA clearance for use during PCI assessment.”
He continued: “The FAST-FFR study was carried out at 10 centres worldwide and evaluated more than 380 patients. The study demonstrated the clinical predictive value across a full range of coronary physiology, including complex lesion assessment in bifurcations and calcified lesions. FAST-FFR also demonstrated that the FFRangio system could perform non-invasive, objective, multi-vessel, physiologic measurements to support PCI decision making.”
Ifat Lavi, CathWorks chief technology officer, Guy Lavi, CathWorks president, and Ran Kornowski, chairman of cardiology at Rabin Medical Center in Israel, invented the CathWorks technology and founded the company six years ago.
Following the 510(k) clearance, Kornowski commented, “When we first collaborated, we were trying to solve a real dilemma that interventional cardiologists faced. Doctors knew that conventional FFR provided valuable objective data, but that came with the cost, risk, and time, that ultimately restricted adoption. With the FDA clearance of CathWorks FFRangio, we believe that we have accomplished our goal of providing doctors with objective data to inform their clinical decision-making without an additional intervention.”