CathWorks Announces FAST-FFR Pivotal Clinical Trial

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[junkie-alert style=”grey”] CathWorks Ltd., a leader in the development of non-invasive Fractional Flow Reserve (FFR) measurements for guiding coronary interventions, announced today that the first patient has been enrolled in the FAST-FFR (FFRangio Accuracy vs. STandard FFR) clinical trial. This global pivotal trial is designed to assess the efficacy of FFRangio™ in measuring FFR derived from coronary angiography compared to invasive FFR. The outcomes of the trial will support CathWorks’ submission to FDA for 510K clearance. [/junkie-alert]

Per the company, the FFRangio™ is a non-invasive, image based software device that provides physicians with clinical information to determine whether an intermediate coronary artery blockage warrants treatment. The FFRangio™ software device generates a FFR index and 3-D reconstruction of the coronary tree based solely upon routine coronary angiograms and hemodynamic information acquired during the coronary angiography procedure, precluding the need for invasive pressure wires and vasodilation treatment. This “Functional Angiography” has the potential to disrupt, and vastly expand the existing FFR market with the ability to correlate anatomy and physiology in-situ, leading to faster and safer diagnosis of intermediate coronary disease.

Bill Fearon, MD, FAST-FFR Principal Investigator and Director of Interventional Cardiology at Stanford University Medical Center said, “The FAST-FFR Trial is a critically important study because it will test the accuracy of FFRangio™, a novel wireless method for assessing fractional flow reserve. If the results of this large, multicenter trial are positive, it could have broad implications on how we diagnose ischemic heart disease in the cath lab.

“We look forward to FAST-FFR building upon, and reinforcing the results of the recently published Validation Study as we work towards FDA market clearance,” added Guy Lavi, President and Founder of CathWorks.

Transcatheter Cardiovascular Therapeutics (TCT), FFRangio Breakfast Meeting, October 31st, 6:30am

During TCT, CathWorks will hold a Breakfast Meeting where several investigators will share their experience from initial usage of the FFRangio technology.