Noninvasive FFR gets a boost from Medtronic


Noninvasive FFR gets a boost from Medtronic
CathWorks FDA-Approved FFRangio™ Receives $75 Million Investment from Medtronic with Potential Acquisition Option for Over Half a Billion

CathWorks FFRangio Display
CathWorks FFRangio Display

July 17, 2022 — Over a decade ago, the FAME study, using Fractional Flow Reserve (FFR), showed that using this physiological measure as a decision-making tool for stent placement not only reduced the number of stents placed, but also improved the results. FFR involved placing a wire through a narrowing seen on coronary artery angiography, infusing the artery with adenosine, and measuring the flow. Any blockage measured above 0.80 was considered insignificant (1.0 is the theoretical open artery). In a number of cases, what looked like a large blockage on the angiogram actually did not cause ischemia and did not require stenting.

But, as we wrote in our 2011 article, “FFR: Why isn’t everyone using it?“, less than 20% of procedures used FFR as a tool. This relatively low adoption rate was due to a number of factors: reimbursement, increased time to perform FFR, increased costs of FFR wire and adenosine, a learning curve, and negative patient reactions to adenosine.

Over the past decade, improvements in physiological measurement have been made. iFR (Philips Medical Systems) was developed in the UK and eliminated the need for adenosine. Equipment and cables have become more airworthy and evidence from a number of studies has accumulated to verify the benefits of FFR. Additionally, several non-invasive modalities have been invented: FFRct, which processes a standard CT scan to measure flow, and FFRangio, which uses real-time real-time angiogram to display FFR readings, without wires or adenosine, and has a short learning curve (5 cases).

FFRangio was developed by CathWorks, an Israeli company, and was approved by the US FDA in 2018, and a year later by the Ministry of Health, Labor and Welfare in Japan. The pivotal study that led to FDA approval, FAST-FFR, showed that angiography-derived FFR was highly accurate compared to pressure-wire FFR.

This week, Medtronic announced it was investing $75 million in the company, co-promoting its use, and has an option to acquire CathWorks for $585 million once certain milestones are met.

Medtronic’s press release follows:


Medtronic Announces Co-Promotion Agreement with CathWorks, with Path Toward Acquisition
— Partnership underlines Medtronic’s commitment to investing in innovative technologies
that support physicians and patients from diagnosis to treatment
— CathWorks’ FFRangio® System Provides Diagnostic and Physiological Information Through Artificial Intelligence to Potentially Disrupt Traditional FFR and Revolutionize Coronary Heart Disease Management

July 12, 2022 — Dublin and Kefar Sava, Israel, — Medtronic plc (NYSE:MDT), a global health technology leader, today announced that it has entered into a strategic partnership agreement with CathWorks, a private company headquartered in Kefar Sava, Israel, which aims to transform the way coronary artery disease (CAD) is diagnosed and treated.

As part of the agreement, Medtronic will invest up to $75 million and immediately begin co-promotion of the CathWorks FFRangio® System in the United States, Europe and Japan, where it is commercially available. Under a separate agreement, Medtronic will have the option to acquire CathWorks once certain undisclosed milestones are met. CathWorks will also have the right to compel Medtronic to acquire the company if Medtronic chooses not to exercise its option. The vesting option agreement will expire in July 2027, with an estimated $585 million acquisition and undisclosed potential follow-up payments after the acquisition. Medtronic has held a minority stake in CathWorks since 2018.

Fractional flow reserve (FFR) is a diagnostic technique that assesses the physiological impact of coronary artery stenosis, making it an important part of the decision-making process when managing patients with coronary artery disease. Although FFR is an important diagnostic tool, supported by strong clinical evidence,[1] the nature of traditional FFR – which requires invasive measurements with wires and stimulation with hyperemic agents – has resulted in its underutilization. Unlike traditional FFR, the FFRangio system combines artificial intelligence (AI) and advanced computer science to obtain fast and reliable FFR values ​​from routine angiograms (X-rays), eliminating the need for drug stimulation and invasive pressure threads.

“Data and AI-driven technologies have been shown to improve patient workflow and outcomes across the entire healthcare ecosystem. In cardiology in particular, these new technological advances offer clinicians the possibility of obtaining additional information to improve and evolve the diagnosis and treatment of patients. with CAD,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, part of Medtronic’s cardiovascular portfolio. “We are delighted to partner with CathWorks to bring the FFRangio system to our customers. We firmly believe in the potential of technology and are committed to strengthening our relationship with CathWorks to deliver new technologies and innovative solutions, from diagnosis to treatment.

Based on strong clinical evidence, FFRangio has demonstrated excellent diagnostic performance compared to wired FFR. According to clinical data published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, FFRangio showed 93% diagnostic accuracy, 91% sensitivity, and 94% specificity.[2]. This non-invasive technology has the potential to disrupt and expand traditional FFR segments. Traditional FFR is now an approximately $750 million product segment that is growing in double digits.

“CathWorks has sought the right partner to help us expand the reach of the FFRangio System globally,” said Ramin Mousavi, President and CEO of CathWorks. “Medtronic not only brings the strength of its commercial team to CathWorks, but a reputation for investing and defining new opportunities to revolutionize care. I am excited about the possibilities that await us as we partner with Medtronic to expand the use of our technology in the United States, Japan and Europe.”

Financial Highlights
The co-promotion agreement is expected to be neutral to Medtronic’s fiscal 2023 GAAP and adjusted earnings per share and neutral to accretive thereafter.

About CathWorks
CathWorks is the leader in digital health innovations that can improve the lives of patients around the world. The CathWorks FFRangio® system combines artificial intelligence and advanced computer science, transforming the way cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiological information from routine angiograms, eliminating the need for drug stimulation and invasive pressure leads. It provides physicians with fast and reliable intraprocedural FFR values ​​for the entire coronary tree, which is convenient for every patient. For more information about CathWorks, visit www.cath.works

and follow @CathWorks on Twitter and LinkedIn.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global health technology company boldly tackling the toughest health challenges facing humanity by researching and finding solutions. Our mission – to relieve pain, restore health and extend life – unites a global team of more than 95,000 passionate people in 150 countries. Our technologies and therapies address 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With our diverse knowledge, insatiable curiosity, and desire to help everyone in need, we deliver innovative technologies that transform two people’s lives every second, every hour, every day. Expect more from us as we deliver insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we design the extraordinary. For more information about Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports filed with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

[1] Bernard De Bruyne, MD, Ph.D., Nico HJ Pijls, MD, Ph.D., Bindu Kalesan, MPH, Emanuele Barbato, MD, Ph.D., Pim AL Tonino, MD, Ph.D., Zsolt Piroth , MD, Nikola Jagic, MD, Sven Möbius-Winkler, MD, Gilles Rioufol, MD, Ph.D., Nils Witt, MD, Ph.D., Petr Kala, MD, Philip MacCarthy, MD, Thomas Engström, MD, Keith G. Oldroyd, MD, Kreton Mavromatis, MD, Ganesh Manoharan, MD, Peter Verlee, MD, Ole Frobert, MD, Nick Curzen, BM, Ph.D., Jane B. Johnson, RN, BSN, Peter Jüni, MD , and William F. Fearon, MD, for investigators of the FAME 2 trial. Fractional Flow Reserve – Guided PCI versus Medical Therapy in Stable Coronary Artery Disease. The New England Journal of Medicine 2012; 367:991-1001DOI: 10.1056/NEJMoa1205361

[2]

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 Cardiovascular Interv. (2020) 13: 488–97. 10.1016/j.jcin.2019.10.045

Reported by Burt Cohen, July 17, 2022

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