CathWorks Announces FAST-FFR Pivotal Clinical Trial

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Oct 24, 2017, 11:00 ET

KFAR SABA, Israel, Oct. 24, 2017 /PRNewswire/ -- 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.

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.

"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," commented Bill Fearon, MD, FAST-FFR Principal Investigator and Director of Interventional Cardiology at Stanford University Medical Center.

"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 31^st, 6:30am

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

About CathWorks

CathWorks is a privately held Israeli company founded in 2013. The company develops digital healthcare products for the cardiovascular market and is focused on improving the utilization of coronary angiography data to ratify measurement-based medicine in the cath lab. CathWorks is backed by worldwide VCs as well as a strategic partner and has completed two series of financing.

For further information, please contact Ilanit Frank-Hakim, [email protected]

SOURCE CathWorks