Market Overview

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


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 p.m. 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 multi-vessel 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
For more information about the course content and presenters, visit

The CathWorks FFRangio 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 FFRangio System to market to provide quick,
precise, and objective intraprocedural FFR guidance that is practical
for every case.

View Comments and Join the Discussion!