CathWorks wins FDA 510(k) for FFRangio

Non-invasive fractional flow reserve tech developer CathWorks said yesterday that it won FDA 510(k) clearance for its FFRangio non-invasive fractional flow reserve analysis technology. The Israel-based company said that approval came based off of results from the FAST-FFR blinded comparative study study which showed that its FFRangio system was accurate when compared to invasive FFR. “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 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,” CEO Jim Corbett said in a press release. The FFRangio system is designed to provide objective FFR guidance for optimizing percutaneous coronary intervention therapy decisions, CathWorks said. FFRangio is derived from routine X-rays during diagnostic angiogram procedures and is performed intra-procedurally during coronary angiography to reduce risk and cost associated with invasive FFR, the co...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Vascular cathworks Source Type: news