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CathWorks FFRangio™ System files FDA 510(k) Submission

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Aug. 22, 2018

KFAR-SABA, ISRAEL (August 22, 2018) — CathWorks announced that it has submitted its CathWorks FFRangio™ System to the United States Food & Drug Administration (FDA) for review and 510(k) market clearance.

The CathWorks FFRangio System is the non-invasive FFR platform that quickly and precisely delivers objective multi-vessel physiologic measurements to cost-effectively optimize and confirm intraprocedural PCI therapy decisions. It is designed to deliver the objective FFR guidance needed to optimize percutaneous coronary intervention (PCI) therapy decisions for every patient.

The FDA 510(k) submission was filed on August 7, 2018. This submission was made possible following early, full enrollment of the FAST-FFR trial.

CathWorks CEO Jim Corbett said, “The FAME trials clearly demonstrated the clinical and economic value of FFR in PCI decision-making. We are confident that the CathWorks FFRangio System meets a real need for patients and physicians, and we expect the system to make non-invasive, wire-free FFR possible in coronary angiograms; reducing wire-related risks and costs.”

Corbett went on to add, “We anticipate 510(k) market clearance by the end of 2018. Given the CathWorks System’s compatibility with major coronary angiogram platforms and a clear CPT code, we expect the system to start benefitting physicians and their patients very soon.”

The CathWorks FFRangio System is in development and is not yet FDA cleared or available for sale within the United States.

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