Medtronic plc is exercising its option to acquire privately held CathWorks for up to $585 million, bolstering its catheterization technological prowess.

The medical device giant has held a minority stake in the Israeli diagnostics firm since 2018 and the pair have been strategic partners since July 2022, when Medtronic invested $75 million in CathWorks for the marketing rights to the CathWorks FFRangio System in the United States, Europe, and Japan. The 2022 partnership gave Medtronic the option to buy CathWorks by July 2027 once certain undisclosed milestones were met.

The acquisition is valued at up to $585 million with potential undisclosed earn-out payments once the deal is complete.

“Medtronic is thrilled to move forward with our option to officially acquire CathWorks. Through our co-promotion agreement, we’ve seen how CathWorks can disrupt the traditional wire-based FFR segment and leverage the power of data and AI to deliver innovative solutions that assist physicians at every step of a patient’s journey, from diagnosis to treatment,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, which is part of Medtronic’s Cardiovascular Portfolio. “This acquisition allows Medtronic to transform the cath lab with a technology that provides real-time data, informs individualized treatment approaches, and drives new standards of care.” 

Evaluating the physiological significance of coronary artery stenosis is essential to improving patient outcomes. Coronary physiology, most commonly assessed using fractional flow reserve (FFR), helps physicians identify which lesions truly cause ischemia. This enables appropriate revascularization for patients who need it, while avoiding unnecessary percutaneous coronary intervention (PCI) in those who do not. FFR is an important diagnostic tool with strong clinical evidence that demonstrates its improved clinical outcomes and economic benefits.^1,2 Despite its proven benefits, traditional wire-based FFR remains underutilized. This is largely due to its invasive nature, which requires the use of pressure wires, pharmacologic hyperemia, and measurements limited to a single transducer location within the vessel.

Alternatively, using a combination of artificial intelligence (AI) and advanced computational science, the CathWorks FFRangio System provides a comprehensive physiological assessment of the entire coronary tree directly from routine coronary angiograms (X-rays). Robust clinical evidence has demonstrated excellent diagnostic accuracy and promising clinical outcomes when compared with wire-based FFR.^3,4  

Using a combination of artificial intelligence (AI) and advanced computational science, the CathWorks FFRangio System is the only angiography-derived system that delivers FFR values along the entire coronary tree, according to the company. In addition, it provides intraprocedural optimization tools, including assessment of the physiological impact of lesion treatment and interactive sizing tools to measure lesion dimensions. Together, these capabilities empower physicians with deeper physiological insights to support confident, patient-centered treatment decisions.*

“We are thrilled to have CathWorks officially become part of the Medtronic family,” Cathworks President/CEO Ramin Mousavi stated. “Our successful co-promotion over the past three years has unlocked significant opportunities in the coronary physiology market through the expanded utilization of our technology. With Medtronic’s vast global footprint, FFRangio will continue to reach even more patients globally. Bringing Medtronic and CathWorks together will create a best-in-class organization focused on driving new standards of care to transform the cath lab.”  

The deal is pending clearance from the United States Federal Trade Commission (FTC). Medtronic expects to receive the agency’s blessing for the purchase by the end of fiscal year 2026 (late April), subject to applicable regulatory approvals and other customary closing conditions. Medtronic and CathWorks will continue to operate independently until the deal is closed.

The acquisition is expected to be immaterial to Medtronic’s fiscal year 2027 GAAP and adjusted earnings per share and neutral to accretive thereafter.

Based in Kfar Saba, Israel, CathWorks develops coronary digital health solutions. The CathWorks FFRangio System combines artificial intelligence and advanced computational science to obtain physiologic information from routine angiograms, thereby eliminating the need for drug stimulation and invasive pressure wires.

Headquartered in Galway, Ireland, Medtronic is the world’s largest healthcare technology company. Its mission—to alleviate pain, restore health, and extend life—unites a global team of more than 95,000 employees across more than 150 countries. The company’s technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more.

*The results of CathWorks FFRangio  are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional evaluation.

References
¹ Bernard De Bruyne, M.D., Ph.D., Nico H.J. Pijls, M.D., Ph.D., Bindu Kalesan, M.P.H., Emanuele Barbato, M.D., Ph.D., Pim A.L. Tonino, M.D., Ph.D., Zsolt Piroth, M.D., Nikola Jagic, M.D., Sven Möbius-Winkler, M.D., Gilles Rioufol, M.D., Ph.D., Nils Witt, M.D., Ph.D., Petr Kala, M.D., Philip MacCarthy, M.D., Thomas Engström, M.D., Keith G. Oldroyd, M.D., Kreton Mavromatis, M.D., Ganesh Manoharan, M.D., Peter Verlee, M.D., Ole Frobert, M.D., Nick Curzen, B.M., Ph.D., Jane B. Johnson, R.N., B.S.N., Peter Jüni, M.D., and William F. Fearon, M.D., for the FAME 2 Trial Investigators. Fractional Flow Reserve–Guided PCI versus Medical Therapy in stable coronary disease. The New England Journal of Medicine 2012; 367:991-1001DOI: 10.1056/NEJMoa1205361
² Fearon et al. Economic Evaluation of Fractional Flow Reserve-guided Percutaneous Coronary Intervention in Patients with Multivessel Disease. Circulation. 2010;122:2545-2550.
³ Witberg G, De Bruyne B, Fearon WF, Achenbach S, Engstrom T, Matsuo H, et al. Diagnostic performance of angiogram-derived fractional flow reserve: a pooled analysis of 5 prospective cohort studies. JACC Cardiovasc Interv. (2020) 13:488–97. 10.1016/j.jcin.2019.10.045
⁴ Tanigaki T, et al. Provision Trial. Data presented at PCR 2025; Paris, France