Medtronic, a global leader in healthcare technology, announced it will exercise its option to acquire CathWorks, a privately held medical device company, which aims to transform how coronary artery disease (CAD) is diagnosed and treated. The intent to acquire CathWorks follows a 2022 strategic partnership with a co-promotion agreement for the CathWorks FFRangio® System in the U.S., Europe and Japan, where it is commercially available. The acquisition is valued at up to $585 million with potential undisclosed earn-out payments post-acquisition.

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“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 the Cardiovascular Portfolio at Medtronic. “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

“We are thrilled to have CathWorks officially become part of the Medtronic family,” said Ramin Mousavi, president and chief executive officer of CathWorks. “Our successful co-promotion over the past three years has unlocked significant opportunities in the coronary physiology market through the expanded utilization of our innovative 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.”

This deal is pending clearance from the United States Federal Trade Commission (FTC). This phase is expected to be completed by the end of Medtronic’s fiscal year 2026, subject to applicable regulatory approvals and other customary closing conditions. At the date of the acquisition closing, CathWorks will then become a part of Medtronic. Medtronic and CathWorks will continue to operate independently until the deal is closed.