Medtronic Plc

OXFORD, England, Feb. 27, 2025 /PRNewswire/ -- Brainomix, a pioneer in stroke AI imaging software and European market leader, has announced a strategic partnership with Medtronic Neurovascular, a global leader in medical technology. The collaboration aims to enhance stroke care for patients across Western Europe by integrating cutting-edge artificial intelligence (AI) solutions into clinical practice, expanding access to life-changing treatments and improving patient outcomes. The Brainomix 360 Stroke platform is powered by state-of-the-art AI algorithms that provide real-time interpretation of brain scans to aid treatment and transfer decisions for stroke patients. Brainomix 360 Stroke was studied in the largest real-world evaluation of stroke AI – involving data from more than 450,000 patients across England over a 5-year period – with results showing a doubling of thrombectomy rates in Brainomix sites, and an additional 37% increase compared with non-evaluation sites. By combining Brainomix's AI-powered imaging technology with Medtronic's expertise in neurovascular treatments, the partnership represents a significant step forward in stroke care. The collaboration will support faster, more accurate diagnoses, enabling healthcare professionals across the region to make better-informed decisions and deliver life-saving interventions more efficiently Dr. Michalis Papadakis, CEO and Co-Founder of Brainomix, underscored the shared vision of both companies: "This partnership with Medtronic is a natural fit, with the leading neurovascular device provider joining forces with the leading stroke AI imaging partner, both aligned around a mutual commitment towards improving stroke care for all patients. We have demonstrated that our software impacts treatment rates, and working with Medtronic, we now have an opportunity together to deliver a solution for stroke networks across Europe that will enable more patients to get access to vital stroke treatments. Dr. Alex Solich, Senior Consultant for Neurointervention at Karolinska University Hospital & Örebro Hospital, emphasized the impact this partnership will have on patient outcomes: "As a stroke physician, I see firsthand the critical importance of speed and precision in delivering life-saving treatment. That's why I'm genuinely excited about the partnership between Medtronic Neurovascular and Brainomix. Combining Medtronic's proven neurovascular technologies with Brainomix's AI-driven imaging has the potential to make a real difference—not just in streamlining workflows, but in giving patients a better chance at recovery. Knowing that we are moving toward more efficient, data-driven decision-making gives me great confidence that we can continue to push the boundaries of stroke care and improve outcomes for countless patients." Key Benefits of the Partnership Transforming Treatment Regionally: Medtronic's established presence in Western Europe will accelerate the adoption of Brainomix's AI technology, ensuring that life-saving innovations reach more hospitals and healthcare providers across the region. Enhanced Diagnostic Accuracy: Integrating Brainomix's AI-powered imaging software with Medtronic's neurovascular solutions will provide healthcare professionals with highly precise diagnostic tools, enabling quicker and more informed decisions crucial for timely stroke treatment. Optimized Clinical Workflows: By simplifying and accelerating stroke detection and intervention, this partnership will help alleviate the burden on healthcare providers and enhance efficiency across hospital networks. About Brainomix Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke and lung fibrosis. With origins as a spin-out from the University of Oxford, Brainomix is an expanding commercial-stage company with offices in the UK, Ireland and the USA, and operations in more than 30 countries. A private company, backed by leading healthtech investors, Brainomix has innovated award-winning imaging biomarkers and software solutions that have been clinically adopted in hundreds of hospitals worldwide. Its first product, the Brainomix 360 stroke platform, provides clinicians with the most comprehensive stroke imaging solution, driving increased treatment rates and improving functional independence for patients. To learn more about Brainomix and its technology visit , and follow us on Twitter, LinkedIn and Facebook. Contacts Jeff Wyrtzen, Chief Marketing & Business Development Officer [email protected] M +44 (0)7927 164210 T +44 (0)1865 582730 Media Enquiries Charles Consultants Sue Charles [email protected] M +44 (0)7968 726585 Logo - SOURCE Brainomix WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Boston Scientific recently announced the first-in-human procedures using its next-generation Faraflex pulsed field ablation (PFA) and mapping catheter. The investigational catheter was built specifically for PFA and mapping, said Dr. Brad Sutton, the chief medical officer of Boston Scientific’s Atrial Solutions Business, which includes PFA systems for treating atrial fibrillation (Afib). In an interview with Medical Design & Outsourcing, Sutton described Faraflex as “a pretty nice blend” of Boston Scientific’s high-density mapping catheter technology — he noted the Intellamap Orion mapping catheter in particular — with “what we think the market needs and patients need moving forward in the PFA world.” At 8 Fr, Faraflex is smaller than Boston Scientific’s 12 Fr Farawave PFA catheter, which the FDA approved with the Farapulse PFA system for treating Afib in January 2024 shortly after Medtronic won the first-of-its-kind FDA approval . Farawave is a single-shot catheter, while Faraflex is a large focal catheter. Boston Scientific said Faraflex is “designed to optimize mapping and ablation in a single catheter with a wide-area tip and high-fidelity sensing electrodes.” Faraflex is a navigation-enabled catheter and “will be integrated into the OPAL HDx Mapping System enabling precise diagnostic mapping to understand arrhythmia mechanism and target ablations accordingly,” the company said. (Boston Scientific added magnetic navigation capabilities to its Farawave catheter and won FDA approval for that upgrade in October 2024). Previously: Catheter design was key for the Boston Scientific Farapulse pulsed field ablation system Sutton described the expandable catheter as a flexible lattice with a pre-specified, nonadjustable shape, 19 sensing electrodes and a next-gen handling system. “We expect it to be atraumatic and easy to navigate to all the nooks and crannies you might expect in the chambers of the heart,” he said. “There was a prototype, sort of first-generation Faraflex that the Farapulse company had developed. They toyed around with it a little bit for atrial flutter on the right side of the heart. It was a catheter that really wasn’t commercially viable, so this is using the same concept but a much more sophisticated design.” Previously: Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J MedTech Pulmonary vein isolation and posterior wall isolation can handle most de novo paroxysmal and persistent AFib cases. “That’s a huge chunk of the market,” Sutton said. “It’s a very easy workflow. It’s not the most intellectually sophisticated, stimulating thing to do because it’s all anatomical, and electrophysiologists love to do more complex ablations. Frankly, there’s a clinical need to do more complex ablations, and single-shot tools aren’t the best set of tools for that.” “If you have a redo patient with a complex atrial arrhythmia and you really need to understand both the electrical substrate, potentially the mechanism of the arrhythmia, where is it coming from, what is the electrical circuit, how do I tackle it, and then anything outside the atrium — the ventricle is its own complex animal and ventricular tachycardia ablation, I think we’re very much on the front end of that journey with PFA, but it’s really promising,” he later continued. “What Faraflex represents is a bit more precision and a much higher fidelity mapping capability to understand the heart tissue itself, how much is scar, what is healthy, and what is the electrical framework and structure and functionality of that chamber of the heart.” Dr. Ante Anic performed the first-in-human procedures in Croatia, observed by Cleveland Clinic Drs. Oussama Wazni and Walid Saliba. Those first cases “went as well as we could have possibly hoped for,” Sutton said, characterizing their feedback on the catheter as an “easy to use, utilitarian sort of tool for anything complex [that] stacks up very favorably to anything they’ve used from the competition.” Sutton said he hopes to launch an investigational device exemption (IDE) trial in the second half of 2025 or early 2026. “Right now, we’re having conversations around the IDE design, leadership of the global study, what that looks like, and looking to understand exactly what the regulatory path is going to be,” he said. Boston Scientific is scheduled to offer more details on April 26 at the Heart Rhythm Society’s annual meeting in San Diego.

Medtronic said its rollout represents the largest-ever commercial launch of a brain-computer interface technology, with more than 40,000 patients worldwide already implanted with Percept neurostimulators. \n Shortly after obtaining a greenlight in Europe and after more than 10 years in development, Medtronic has now received the FDA’s approval for its adaptive, closed-loop neurostimulation approach to treating the motor symptoms that come with Parkinson’s disease.The company said its U.S. rollout represents the largest-ever commercial launch of a brain-computer interface technology, with Medtronic’s BrainSense platform reading changes in a patient’s neural activity in real-time and then adjusting therapy to suit. While deep-brain stimulation has been available to patients for decades—through implants that send electric signals similar to how pacemakers connect with the heart—adaptive stimulation aims to personalize therapies during daily life.In a real-world clinical study published last year, data showed that by reading activity in the areas of the brain linked with Parkinson’s, including the globus pallidus internus and subthalamic nucleus, the device could detect a user’s “on” or “off” phases—with motor and non-motor symptoms being the strongest during off periods, which typically come in-between medication doses.By targeting neurostimulation to the off phase, the study’s initial findings showed the implant could help reduce the need for medication while also minimizing the side effects that can occur when deep-brain therapy and peak drug levels overlap. Dubbed ADAPT-PD, the trial’s full results are expected in the future.“Our BrainSense technology provides unique and clinically important insights that no other DBS system can offer, using a person\'s own brain signals to provide a window into their condition, in real time, over time,” Paolo Di Vincenzo, president of Medtronic’s neuromodulation business, said in a statement.“Our focus has always been on creating solutions that work for real lives, not just standalone symptoms,” Di Vincenzo added. “aDBS reflects that commitment, bringing a new expectation in Parkinson\'s treatment.” BrainSense will be available through the company’s Percept neurostimulator implants. Medtronic previously set the stage for the technology with an FDA approval in 2021 for deep-brain stimulation hardware that could sense and record changes in local electric field potentials.Now the adaptive program can be programmed into already implanted devices wirelessly, essentially as a software update. Alongside the announcement of a CE mark approval in January, the company said the first patient began receiving the feature the same day. Medtronic said more than 40,000 patients worldwide with Percept devices may be eligible for the therapy.And like in Europe, the FDA’s green light also includes the BrainSense Electrode Identifier, which Medtronic said can help reduce the amount of time patients need to spend in the clinic to calibrate their deep-brain stimulation settings by displaying their personal neural activity.Medtronic said patient programming in the U.S. will begin at select healthcare systems in the next few weeks, with nationwide availability in the coming months.