Case study: FFR from three X-ray angiograms, the 3D coronary reconstruction behind CathWorks' FFRangio

Summary: Vision Elements conceived and built the 3D reconstruction and flow-analysis technology that lets CathWorks' FFRangio System compute fractional flow reserve from standard angiograms during a catheterization, without a pressure wire.

The challenge

Coronary artery disease is a leading global cause of death. Fractional flow reserve (FFR) measures the pressure drop across a narrowing; values below 0.75–0.80 predict ischemia. Wire-based FFR needs a pressure guidewire, a hyperemic agent, and measures only one point, so it is underused. The question was whether the same physiology could be derived from the 2D X-ray angiograms every cath lab already acquires, in real time, while the patient is on the table.

What we did

Guy Lavi, founder of Vision Elements and founder and former CEO of CathWorks, invented the core reconstruction approach; Vision Elements provided the research and development. Three angiographic projections are matched vessel-by-vessel and compensated for cardiac and respiratory motion to build a 3D coronary tree. Vascular resistance is derived from that geometry and the tree is modeled as a resistance network. A virtual revascularization computes the vessel without the stenosis, so the ratio of diseased flow (QS) to revascularized flow (QN) captures each lesion's functional impact, giving FFR along every vessel. Vision Elements developed the core AI algorithms from sketches to operational code, led the real-time engine, contributed to drafting most of the patent portfolio, and assigned 100% of the IP to CathWorks.

Outcome

FFRangio holds FDA 510(k) clearance (2018), CE Mark (2017), Japan PMDA approval (2019) and EU-MDR approval (2024). A 2020 pooled analysis of five prospective cohorts showed the highest diagnostic accuracy among non-hyperemic and angiography-based indices; the PROVISION randomized trial found FFRangio non-inferior to wire-based FFR. After a co-promotion partnership that began in 2022, Medtronic announced on 3 February 2026 its intent to acquire CathWorks in a deal valued at up to $585 million.

Why it matters for your project

This is regulatory-grade computer vision: a reconstruction that must be right, not merely plausible, built under real-time constraints and defended with patents and clinical trials. If your product extracts 3D structure or physical quantities from limited 2D views, the same methods and engineering discipline apply.

FAQ

Does the method need special imaging hardware? No. It uses standard 2D X-ray angiograms acquired during routine catheterization.

Who owns the IP developed in an engagement like this? In the CathWorks work, 100% of the IP was assigned to the client.

How involved was Vision Elements? From concept and proof of principle through the real-time production engine.

Contact: info@vision-elements.com