Cardiology · Angiography-derived coronary physiology
FFRangio System
CathWorks (a Medtronic company)
The pressure wire that isn't there — FFRangio reads lesion-level coronary physiology off the angiogram already on the screen, and in March 2026 the 1,924-patient ALL-RISE trial in the New England Journal of Medicine showed that strategy holding its own against the wire itself. Cleared in the US since 2018, MDR-certified in Europe, nationally reimbursed in Japan, and since April 2026 the centrepiece of Medtronic's push into AI-guided coronary intervention.
Performance Metrics
Clinical Evidence
The evidence arc runs from bench accuracy to randomised outcomes, which is still rare in this catalogue. The pivotal FAST-FFR study (Circulation, 2019) enrolled 301 patients and 319 vessels across 10 international centres: operators blinded to wire FFR computed FFRangio on-site, and against the pressure wire as reference the per-vessel sensitivity was 94 percent and specificity 91 percent, with a mean FFR of 0.81 and 43 percent of vessels at or below the 0.80 treatment threshold — squarely the intermediate-lesion territory where physiology changes decisions. A patient- and lesion-level pooled analysis of five prospective cohort studies (JACC: Cardiovascular Interventions, 2020; 588 patients, 700 lesions) reported 91 percent sensitivity, 94 percent specificity and 93 percent overall accuracy, consistent across subgroups including acute coronary syndrome presentations. The step most angiography-derived FFR tools have not taken came in March 2026: ALL-RISE (New England Journal of Medicine), a randomised trial of 1,924 patients across 59 sites in the United States, Japan, Israel, Switzerland and the United Kingdom, compared an FFRangio-guided strategy head-to-head against pressure-wire-guided management of intermediate lesions. The primary composite of death, myocardial infarction or unplanned clinically indicated revascularisation at one year occurred in 6.9 percent of the FFRangio group versus 7.1 percent with the wire, meeting noninferiority — with less radiation exposure, less contrast use and shorter assessment and procedure times in the FFRangio arm. An international multicentre registry of FFRangio-guided treatment (Cardiovascular Revascularization Medicine, 2026; PMID 41620337) adds real-world texture: at a median 365 days, deferred patients had a 1.6 percent primary-endpoint rate against 6.8 percent in the revascularised group, and outcomes were markedly better where treatment followed the FFRangio verdict than where it departed from it (3.6 versus 8.7 percent). One caution for the literature search: the similarly named FAST, FAST-II and FAST-III studies evaluate a different vendor's vessel-FFR software. The CathWorks trials are FAST-FFR and ALL-RISE — conflating the two families overstates (or understates) either product's evidence base.
| Study | Design | n | Sensitivity | Specificity | AUC | Published |
|---|---|---|---|---|---|---|
| Fearon WF, Achenbach S, Engstrøm T, et al. (FAST-FFR) | ProspectiveProspective | 301 | 94% | 91% | — | Circulation, Jan 2019; 319 vessels across 10 international centres; on-site operators blinded to wire FFR; mean FFR 0.81, 43% of vessels ≤0.80 |
| Witberg G, De Bruyne B, Fearon WF, Achenbach S, Engstrøm T, Matsuo H, Kornowski R (pooled analysis of 5 prospective cohorts) | ProspectiveProspective | 588 | 91% | 94% | — | JACC: Cardiovascular Interventions, Feb 2020; 700 lesions; 40% acute coronary syndrome presentations; performance consistent across patient and lesion subgroups |
| Fearon WF, et al. (ALL-RISE Investigators) | RCTRCT | 1,924 | — | — | — | New England Journal of Medicine, Mar 2026; 59 sites in the US, Japan, Israel, Switzerland and the UK; death/MI/unplanned revascularisation at 1 year 6.9% vs 7.1% for pressure-wire guidance (noninferior), with lower radiation, contrast use and procedure time |
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Inside the Auris+ Listing
Five more sections complete this device’s Auris+ Listing.
Decision Ledger
ProPro unlocks a private, cross-vendor log of every case you read on this device — what the AI called, what you concluded, and a one-line reason if you overrode it. Ready for the EU AI Act's deployer logging obligations when they land in 2028.
Clinical Evidence Deep Dive
ProPro unlocks the structured clinical-evidence summary — study count, target patient population, and a tabular accuracy-metrics view drawn from peer-reviewed sources.
Peer-Reviewed Publications
ProPro unlocks the curated peer-reviewed publication list with PubMed cross-links — the citation backbone of every editorial verdict.
Post-Market & Regulatory Conditions
ProPro unlocks the post-market surveillance summary, recall record, and the conditions of approval that bound real-world use.
AI Algorithm Version History
ProPro unlocks the chronological record of algorithm version changes — what changed when, drawn from manufacturer changelogs and regulatory filings.
Regulatory Approvals
Safety Record
No recall, field safety notice or FDA safety communication for FFRangio was located in any source accessible to this review, and the randomised ALL-RISE comparison showed no excess in death, myocardial infarction or unplanned revascularisation against wire-based management. The system is analysis software layered on imaging already acquired: it does not touch the patient, deliver energy or therapy, or steer hardware in the vessel, which limits the direct harm surface to the quality of the number it produces — the failure mode that matters is a wrong physiological verdict steering a revascularisation decision, which is precisely what the randomised endpoint bounded. A direct MAUDE adverse-event query could not be run this review cycle (register egress blocked); the absence of a MAUDE signal here rests on secondary-source review and should be re-run against the register directly.
Intended Use & Indications
FFRangio is a software device that analyses previously acquired coronary angiography DICOM data in patients with coronary artery disease. Based on angiograms acquired in two or more different projections, it generates a 3D computer model of the coronary tree and computes FFRangio, a mathematically derived quantity obtained from simulated blood-flow information, intended to support the functional evaluation of coronary artery disease. Unlike wire-based fractional flow reserve, the assessment is performed intra-procedurally without placing a pressure guidewire in the vessel and without administering a hyperaemic stimulus such as adenosine; unlike CT-derived physiology, it operates on the invasive angiogram during the index procedure rather than upstream of it. The output is displayed as FFR values across the coronary tree. The device is a decision-support tool — revascularisation decisions remain with the treating physician.