Tag: FAST-FFR

FAST-FFR Pivotal Trial Added to TCT 2018 Late-Breaking Clinical Trial Program

KFAR-SABA, Israel–(BUSINESS WIRE)–CathWorks announced that the FAST-FFR pivotal trial has been added to the late-breaking clinical science program during the 2018 TCT (Transcatheter Cardiovascular Therapeutics) annual meeting in San Diego. FAST-FFR trial data will be presented in the Main Arena during the late-breaking science session that begins at 12 noon […]

CathWorks FFRangio™ System Files FDA 510(k) Submission

KFAR-SABA, Israel–(BUSINESS WIRE)–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 […]

CathWorks FAST-FFR Trial Enrollment Completed Early

KFAR-SABA, Israel–(BUSINESS WIRE)–CathWorks announced that its FAST-FFR trial is fully enrolled ahead of schedule. The trial 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 […]