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

The FAST-FFR pivotal trial was designed to evaluate the efficacy of the CathWorks FFR_angio™ 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 FFR_angio System will also be featured in a TCT Lunch Presentation Theater program titled “FFR_angio for PCI Guidance: A Clinical Review”. The program will be presented on September 24, 2018 at 1:00 p.m. in Presentation Theater 5 during the conference.

The program will feature a global panel of experts discussing their experiences with the CathWorks FFR_angio 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 FFR_angio in multi-vessel disease, and 4) How daily use of CathWorks FFR_angio 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 FFR_angio System is not FDA-cleared and is not yet available for sale within the United States.

About CathWorks

CathWorks is a medical technology company focused on applying its advanced computational science platform to optimize PCI therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians. FFR-guided PCI decision-making is proven to provide significant clinical benefits for patients with coronary artery disease and economic benefits for patients and payers. The company’s focus today is specifically on bringing the CathWorks FFR_angio System to market to provide quick, precise, and objective intraprocedural FFR guidance that is practical for every case.