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

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

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.

CathWorks FFRangio™ System files FDA 510(k) Submission

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.

Learn how the CathWorks FFRangio System can impact your practice.

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