KFAR-SABA, ISRAEL (August 29, 2018) — 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 on Monday, September 24.
The FAST-FFR pivotal trial was designed to evaluate the efficacy of the CathWorks FFRangio™ System in terms of sensitivity and specificity when compared to conventional invasive FFR. Trial enrollment began September 27, 2017 and the final patient was enrolled just eight (8) months later on June 7, 2018. The FAST-FFR pivotal trial was performed at ten leading cardiovascular centers including University of Erlangen in Germany, Stanford University, Columbia University, St. Francis Hospital, and University of Pennsylvania in the United States; Rabin Medical Center, Share Zedek Medical Center and HaSharon Medical Center in Israel; OLV Aalst in Belgium; and Rigs Hospital CPH in Denmark.
In addition to inclusion in the late-breaking clinical trials program, the CathWorks FFRangio System will also be featured in a TCT Lunch Presentation Theater program titled “FFRangio for PCI Guidance: A Clinical Review”. The program will be presented on September 24, 2018 at 1:00 PM in Presentation Theater 5 during the conference.
The program will feature a global panel of experts discussing their experiences with the CathWorks FFRangio System. Presentations will include: 1) In-depth review of FAST-FFR pivotal trial results, 2) Deep dive into FAST-FFR subgroups and secondary endpoints, 3) The benefits of CathWorks FFRangio in multivessel disease, and 4) How daily use of CathWorks FFRangio System can change clinical practice in the future.
The Presentation Theater Program is free of charge, open to all registered TCT attendees, and lunch will be served. Seating is limited. You can register online at www.crf.org/tct/agenda/satellite-programs. For more information about the course content and presenters, visit www.cath.works.
The CathWorks FFRangio System is not FDA-cleared and is not yet available for sale within the United States.