CathWorks has announced that its FAST-FFR trial is fully enrolled ahead of schedule, whch is designed to evaluate efficacy of the CathWorks FFRangio system in terms of sensitivity and specificity when compared to conventional invasive Fractional Flow Reserve (FFR).
Enrollment in the trial began on September 27, 2017 and enrollment of all 382 subjects was completed just eight (8) months later on June 7, 2018.
FFR is an invasive technique used to measure pressure differences across a stenosed area in the coronary arteries. CathWorks FFRangio System is non-invasive and performed intra-procedurally, during coronary angiography.
The system is designed to enable physicians to objectively and cost-effectively determine if PCI (percutaneous coronary intervention) is indicated, without an additional intervention during the course of a routine diagnostic angiography.
The FAST-FFR trial is being conducted at ten leading cardiovascular centers around the world using various coronary angiography platforms.
The FAST-FFR trial principal investigator William Fearon said: “As interventional cardiologists, we want objective multi-vessel physiologic measurements to make PCI decisions, which can be performed easily and with as low risk and cost as possible.
“We look forward to the data analysis and understanding how CathWorks FFRangio System data compares to pressure wire-derived FFR.”
CathWorks CEO Jim Corbett said: “Early enrollment of the FAST-FFR trial population confirms interventional cardiologists’ excitement about cost-effectively adding a new level of objectivity in PCI decision-making.”
The CathWorks FFRangio System is in development and is not yet FDA cleared or available for sale within the United States.
CathWorks is a medical technology company focused on applying its advanced computational science platform to optimize PCI therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians.
FFR-guided PCI decision-making is proven to provide significant clinical benefits for patients with coronary artery disease and economic benefits for patients and payers.
Source: Company Press Release