Medtronic has completed its acquisition of CathWorks, developer of the FFRangio, artificial intelligence (AI)-powered, non-invasive imaging software for diagnosis and treatment of coronary artery disease (CAD).
The acquisition follows a 2022 strategic partnership with a co-promotion agreement for the FFRangio system where it is commercially available in the USA, Europe and Japan. The acquisition is valued at US$585 million with potential undisclosed earn-out payments post-acquisition.
“With the acquisition of CathWorks by Medtronic, we are boldly redefining the future of cardiovascular care,” said Ramin Mousavi, president and chief executive officer of CathWorks. “As I reflect on our long-term partnership, I am deeply grateful and proud of what we’ve accomplished together. This deal is a testament to CathWorks’ and Medtronic’s shared commitment, vision, and relentless drive to revolutionize the cath lab and deliver better solutions for patients living with cardiovascular disease. Together, we have ushered in a new dawn in cardiovascular diagnosis and patient outcomes.”
The FFRangio system provides a comprehensive physiological assessment of the entire coronary tree directly from routine drug-free, wire-free coronary angiograms. This differs from traditional wire-based fractional flow reserve (FFR) assessment, which requires the use of pressure wires, pharmacologic hyperaemia, and measurements limited to a single transducer location within the vessel.
The announcement follows recent one-year results from the ALL-RISE randomised control trial at the American College of Cardiology’s annual scientific session (ACC.26; 28–30 March, New Orleans, USA). The trial, including more than 1,900 patients across 59 sites in North America, Asia, Europe and the Middle East, demonstrated that CathWorks FFRangio is non-inferior to wire-based physiology in terms of major adverse cardiac events (MACE) at one year, with improved resource utilisation and reduced procedure time benefits.
“The acquisition of CathWorks significantly enhances Medtronic’s interventional cardiology portfolio with an innovative system that empowers physicians with data-driven insights for the diagnosis and treatment of coronary artery disease,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, part of the Cardiovascular Portfolio at Medtronic. “Through our global footprint, welcoming CathWorks to Medtronic will expand access to the transformative FFRangio technology for our customers and their patients worldwide.”
Medtronic has also made a leading investment in Pulnovo Medical, a specialist in therapies for treating pulmonary hypertension and heart failure, part of a total US$100 million strategic financing round closed by Pulnovo. Medtronic and Pulnovo have entered into a commercial agreement that contemplates potential future commercialisation opportunities.
Pulnovo’s proprietary pulmonary artery denervation (PADN) system targets a key underlying mechanism of cardiopulmonary disease. To date, the company has performed 1,500 PADN procedures globally and has secured regulatory approvals in seven countries, supporting its expanding international footprint. The company is advancing commercialisation across the European Union (EU), Middle East, and China. In the USA, Pulnovo has received US Food and Drug Administration (FDA) breakthrough device designation and has initiated two fully approved investigational device exemption (IDE) trials, led by Gregg Stone (Mount Sinai Health System, New York, USA).
“Through the integration of industry expertise and long-term capital, Pulnovo is building a scalable growth model anchored in proprietary innovation, global clinical development, and strategic ecosystem partnerships. This financing marks a pivotal transition from a product-driven phase to a fully integrated global platform. As we continue to strengthen our capabilities across both clinical and technological fronts, we remain committed to delivering meaningful innovation to patients worldwide,” said Cynthia Chen, chairlady and president, Pulnovo Medical.
