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 company 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,” device co-inventor Dr. Ran Kornowski of Israel’s Rabin Medical Center said in a prepared statement.
In July, CathWorks said that it won a new CPT code covering its 3D FFRangio non-invasive fractional flow reserve analysis technology.
