Heart Care MedTech Company CathWorks Receives FDA Clearance

Israel-based medical technology company CathWorks, which develops devices for the interventional cardiology market announced that its FFRangio System received US Food & Drug Administration (FDA) clearance.

CathWorks developed the FFRangio System, a non-invasive device that delivers FFR (Fractional flow reserve) guidance to optimize Percutaneous Coronary Intervention (PCI) therapy decisions. FFRangio is derived from routine X-rays acquired during a diagnostic angiogram procedure and performed intra-procedurally during coronary angiography. The device provides a 3D reconstruction of the coronary tree with FFR values along each vessel.

Jim Corbett, CathWorks CEO said, “The FDA clearance of CathWorks FFRangio is a significant 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 Percutaneous Coronary Intervention (PCI) assessment. The FAST-FFR study was carried out at 10 centers world-wide 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.”

Dr. Kornowski,  Chairman of Cardiology at Rabin Medical Center in Israel, who invented the CathWorks technology alongside co-founders Dr. Ifat Lavi and Guy Lavi, said, “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. We want to express our deep appreciation for the support of our clinical development partners in Israel, the United States, Europe and Japan in realizing this goal,” he added.

CathWorks was founded in 2013 and is headquartered in Kfar Saba. The medtech company raised $15.8 million in a series B funding round in October 2017, led by Quark Venture and Triventures, according to Crunchbase.