Technology | FFR Technologies | December 21, 2018

CathWorks FFRangio System Receives U.S. FDA Clearance

Enables non-invasive, objective functional evaluation of multi-vessel coronary artery disease

CathWorks FFRangio System Receives U.S. FDA Clearance

 

December 21, 2018 — CathWorks announced that its FFRangio System received U.S. Food  and Drug Administration (FDA) 510(k) clearance. The FFRangio system demonstrated accuracy versus the invasive fractional flow reserve (FFR) wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial equivalence of the FFRangio system.

The CathWorks FFRangio System quickly and precisely delivers the objective FFR guidance needed to optimize percutaneous coronary intervention (PCI) therapy decisions. FFRangio is derived from routine X-rays acquired during a diagnostic angiogram procedure, is non-invasive and performed intra-procedurally during coronary angiography, eliminating additional clinical risk, time and cost associated with invasive FFR. The system provides a 3-D reconstruction of the entire coronary tree with FFR values along each vessel.

The FAST-FFR study was carried out at 10 centers worldwide and evaluated more than 380 patients. The study demonstrated the clinical predictive value across a full range of coronary physiology, including complex lesion assessment in bifurcations and calcified lesions. FAST-FFR also demonstrated that the FFRangio system could perform non-invasive, objective, multi-vessel, physiologic measurements to support PCI decision-making

Read more about the trial in the article "FAST-FFR Trial of FFR-angio Technology Meets Primary Endpoint, Exceeded Performance Goals."

Watch the VIDEO: Angiography Image-based FFR May Eliminate Need for Pressure Wires, an interview with William Fearon, M.D.

For more information: www.cath.works

Related Content

Medivis Launches SurgicalAR Augmented Reality Platform
Technology | Advanced Visualization | February 14, 2019
Medical imaging and visualization company Medivis officially unveiled SurgicalAR, its augmented reality (AR) technology...
Videos | Advanced Visualization | December 12, 2018
This is an example of the FDA-cleared OpenSight augmented reality (AR) system for surgical planning from NovaRad at t
Nihon Kohden Launches Augmented Reality Electrophysiology Training App at HIMSS18
Technology | Advanced Visualization | March 06, 2018
Nihon Kohden announced the launch of the Nihon Kohden Dimensions Augmented Reality (AR) App to complement the Clinical...
NIH Issues $2.2 Million Grant for Augmented Reality Cardiac Hologram Research
News | Advanced Visualization | February 15, 2018
February 15, 2018 — The National Institutes of Health (NIH) awarded a $2.2 million research grant to healthcare techn
EchoPixel Showcases Next-Generation Surgical Planning With True 3-D Interactive Mixed Reality Software
News | Advanced Visualization | January 08, 2018
EchoPixel showcased the latest version of True 3D, its interactive, mixed reality software solution at the 103rd Annual...
Videos | Advanced Visualization | December 07, 2017
Dianna Bardo M.D., director of body MR and co-director of the 3-D Innovation Lab at Phoenix Children's Hospital, disc
Vital Unveils Newest Vitrea Advanced Visualization Release at RSNA 2017
Technology | Advanced Visualization | December 04, 2017
December 4, 2017 — Vital Images unveiled the newest version of Vitrea...
Arterys Completes Series B to Accelerate Product Commercialization
News | Advanced Visualization | November 15, 2017
Arterys Inc. announced the close of its $30M Series B financing round. The investment was led by Temasek, with...
TeraRecon Introduces 175-Plus New Features in iNtuition 4.4.13
Technology | Advanced Visualization | November 06, 2017
November 6, 2017 — TeraRecton announced the launch of version 4.4.13 of its iNtuition...
TeraRecon Enhances Speed, Clinical Capabilities With Latest iNtuition Release
Technology | Advanced Visualization | October 25, 2017
October 25, 2017 — TeraRecon announced the release of version 4.4.13 of their iNtuition software, bringing over 175 n
Overlay Init