SCAI Endorses CathWorks FFRangio Technology

NEWPORT BEACH, Calif., Feb. 4, 2026 /PRNewswire/ -- CathWorks, a global leader in digital health innovations, announced that the Society for Cardiovascular Angiography & Interventions (SCAI) published an expert opinion discussing the expanding role of angiography-derived physiology (ADP), a wire-free method for coronary physiologic assessment. By applying different principles, in some cases in conjunction with artificial intelligence (AI), ADP provides physiologic insights from routine angiograms, representing a paradigm shift in the catheterization lab.

The expert opinion focused on the technological differences between current FDA-approved ADP technologies and their peer-reviewed validation and outcomes studies. The CathWorks FFRangio^® System is a unique ADP that combines AI and advanced computational science to obtain physiologic information from three routine angiograms leveraging a resistance-based computational approach. "FFRangio is the only technology that provides multivessel FFR values across the entire coronary tree, including side branches. It also offers a simulated pullback to differentiate functional disease and supports PCI planning, which is more limited in other systems," as stated in the expert opinion.

CathWorks FFRangio has demonstrated excellent diagnostic accuracy and promising clinical outcomes while eliminating the drawbacks associated with traditional physiology including the need for an invasive pressure wire, anticoagulation or hyperemic agents. In a pooled analysis of five prospective studies including the FAST-FFR pivotal study, CathWorks FFRangio demonstrated an excellent diagnostic accuracy of 93%.¹ CathWorks FFRangio has also shown comparable one-year major adverse cardiac event (MACE) rates to invasive FFR in both real-world registries^2-3 and the PROVISION randomized controlled trial (RCT) that included 400 patients.⁴

The SCAI expert opinion clearly outlines that ADP systems vary widely between imaging requirements, workflow integration and computational approaches and that clinical data should be interpreted in the context of platform-specific validation. The published document highlights that CathWorks FFRangio is the only FDA-approved ADP platform that:

• Provides comprehensive multi-vessel coronary physiology and a suite of PCI planning tools
• Demonstrated excellent diagnostic accuracy consistently across multiple peer-reviewed validation studies¹
• Showed comparable clinical outcomes to invasive FFR at one year in both real-world registries^2-3 and a RCT⁴

"With the rapidly expanding clinical evidence base for CathWorks FFRangio, we look forward to the U.S. and European guidelines incorporating peer-reviewed evidence-based technology specific recommendations that will broaden adoption of physiology overall, ultimately optimizing procedural decision-making and improving patient outcomes," said Ramin Mousavi, President and CEO of CathWorks.

ARTICLE URL: https://www.jscai.org/article/S2772-9303(25)01602-3/fulltext

1. Witberg G et al. Diagnostic performance of angiogram-derived fractional flow reserve: a pooled analysis of 5 retrospective cohort studies. J Am Coll Cardiol Intv. 2020;13(4):488-97.
2. Witberg G et al. Mid-term clinical outcomes of FFRangio guided treatment for coronary artery disease: insights from an international multicentre registry. Cardiovasc Revasc Med. 2026;23:S1533-8389(26)00013-8.
3. Sara JDS et al. Clinical implementation of FFRangio for resvascularization guidance: multicenter U.S. experience, as presented at TCT 2025.
4. Tanigaki T et al. Prospective randomized clinical outcomes of angiography-based fractional flow reserve guidance versus wire-based fractional flow reserve, PROVISION Trial, as presented at EuroPCR 2025. UMIN clinical registry ID: UMIN000049230.

For more information on CathWorks, visit www.cath.works