Medtronic Plc

GALWAY, Ireland and CHICAGO, March 30, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic valve replacement (TAVR) system delivers a numerically lower rate of all-cause mortality or disabling stroke at five years, strong valve performance and durable clinical outcomes. The findings were presented as late-breaking clinical science at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in the JACC, the flagship journal of the American College of Cardiology. The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk <3%, as assessed by a local heart team. 1,414 patients were randomized, with 730 receiving TAVR with either a Medtronic Evolut R, PRO, or CoreValve™ and 684 undergoing surgery. "Results at five years support Evolut's supra-annular, self-expanding TAVR as a safe, effective, and durable alternative to surgery for patients with severe aortic stenosis, regardless of their surgical risk," said Michael J. Reardon, M.D., Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital and principal investigator of the trial. "The lower mortality risk and strong valve performance is meaningful for clinicians in evaluating treatment approaches that prioritize the overall well-being of patients." Patients with severe aortic stenosis who were treated with either Evolut TAVR or surgery showed comparable rates of all-cause mortality or disabling stroke at 5 years (Evolut TAVR [15.5%] and surgery [16.4%]; p=0.47). Additional findings at five years include: Numerically lower rate of cardiovascular mortality (7.2% Evolut TAVR vs. 9.3% surgery; p=0.15) Significantly larger effective orifice areas (EOA) and lower mean gradients in the TAVR vs. surgical arms "At five years, Evolut has demonstrated lasting clinical outcomes comparable to surgery and a trend toward reduced cardiovascular mortality," said Kendra J. Grubb, M.D., M.H.A., M.Sc., vice president and chief medical officer of Structural Heart, which is part of the Medtronic Cardiovascular Portfolio. "These results reinforce the recently reported Evolut evidence from the SMART trial,[1] which emphasized superior hemodynamics and lower rates of valve dysfunction. The Evolut Low Risk data presented today will help clinicians make personalized treatment decisions for younger, lower-risk patients by considering each patient's unique needs, now acknowledging that data supports TAVR with Evolut as a safe and durable alternative to surgery." About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit , and follow @Medtronic on LinkedIn. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Contact: Kimberly Powell Public Relations +1-202-498-2601 Ryan Weispfenning Investor Relations +1-763-505-4626 1Herrmann H. Two-Year Outcomes of the Five-Year SMART Trial, presented at CRT 2025. SOURCE Medtronic plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Abbott, Dexcom, Insulet, Medtronic and more are developing next-gen sensors, pumps and algorithms to offer new options for hundreds of millions of diabetes patients. More than 90% of people with diabetes have type 2 diabetes, but most of the diabetes technology on the market is for type 1 patients. That’s something diabetes device developers are hoping to change as they adapt miniaturized, automated type 1 technology for the much larger type 2 patient population. The International Diabetes Federation projects approximately 783 million people will be living with diabetes by 2045. “The people who need insulin therapy in type 2 also deserve to have a much easier, reduced burden,” Insulet CEO Jim Hollingshead said in an interview shortly before his company’s Omnipod 5 became the first automated insulin delivery (AID) system cleared by the FDA for type 2 last year. More AID systems are in development, while continuous glucose monitor (CGM) makers are also bringing more options to type 2 diabetes patients. “We have much work to do as an industry to really bring to the type 2 population the technologies and brands that are pretty well covered and supplied into that smaller type 1 population,” Abbott EVP of Diabetes Care Chris Scoggins said as his company pushed forward with type 2 tech last year. What is different about developing tech for the type 2 population? Diabetes device companies had already developed much of the technology needed for the type 2 population. In fact, many type 2 patients were using type 1 systems off label before regulatory authorization. Insulin pumps, for example, don’t need hardware changes to expand to type 2, but the algorithms that ensure the safe and effective delivery of insulin need adjustments. Insulin can cause serious complications if under- or over-delivered. Some type 2 patients don’t even need insulin, unlike type 1, which always requires dosing to make up for a patient’s inability to naturally produce enough insulin. Type 2 patients may need more insulin over time as the chronic disease progresses. Tandem Diabetes Care President and CEO John Sheridan said it’s “a natural evolution” to bring AID systems beyond type 1 and into the type 2 population. His company’s Control-IQ+ AID algorithm won the second FDA clearance for type 2 patients in February. Insulet and Tandem both recruited more than 300 subjects for clinical trials to win their type 2 clearances. Insulet also targeted health equity in its trial, Hollingshead said, with the type 2 population often featuring significant ethnic and socioeconomic diversity. The system, which needed to keep A1c in range and avoid an increase in hypoglycemia in the study, delivered “very efficacious, very safe” results with no adverse effects and “terrific clinical benefit,” including reduction of diabetes distress, Hollingshead said. Medtronic plans to follow Insulet and Tandem with an FDA submission for type 2 this year. Beta Bionics, which developed the iLet bionic pancreas, has FDA clearance for type 1 diabetes. Expanding a type 1 diabetes system’s indication to type 2 is “exceedingly important [but] tough,” co-founder Ed Damiano said on a panel in March. Beta Bionics has a couple thousand users managing their type 2 diabetes with the iLet off-label, Damiano said, and his company may seek an indication for that population. Another notable AID developer that hasn’t yet moved into type 2 is Sequel Med Tech. The company is beginning commercial efforts for its Twiist system after integrating the pump with Abbott CGMs . While Twiist’s current indication covers type 1, CEO and co-founder Alan Lotvin said the company is kicking off a clinical trial for type 2. The window may be closing for potential AID competitors. Embecta received FDA clearance for a disposable, open-loop type 2 patch pump last year, but killed the product within months instead of pushing toward its goal of launching an automated system for type 2. “The pump market has continued to evolve, and we anticipate that competition in closed-loop type 2 indicated products may continue to intensify and our offering would require incremental investments to be market competitive,” Embecta CEO Dev Kurdikar explained at the time. “… Upon FDA clearance of our open-loop pump … we performed a market check to identify potential opportunities that would allow us to monetize the asset. Since that did not surface any viable options, we acted promptly to discontinue the program.” Meanwhile, Modular Medical is commercializing its MODD1 product , a 90-day patch pump that features new microfluidics technology for low-cost pumping of insulin for type 1 and type 2. Users can monitor the pump activity with their cell phone and do not need an external controller. The pump uses a single-use, disposable battery. Modular Medical’s aim is to bring a reliable, smaller form factor at a low cost to serve those “neglected by the industry,” CEO Jeb Besser said in an interview. “Our target is not the ultra sophisticated, super-high-functioning user,” he said. “There are lots of products on the market today that do a good job of serving that user.” Type 2 tech beyond AID systems The developers of CGMs that integrate with those insulin pump technologies also have their eyes on the type 2 opportunity. Dexcom and Abbott’s CGMs have been available for the type 2 population for years, but have now launched over-the-counter (OTC) CGMs for type 2 patients who don’t use insulin. Dexcom won the first such FDA clearance with its Stelo glucose biosensor. The company estimates approximately 25 million type 2 patients in the U.S. don’t use insulin but could benefit from CGM use. Someone who currently has insulin dependence has to worry about controlling glucose in the present, Dexcom Chair and CEO Kevin Sayer said after winning that clearance, while a person who doesn’t use insulin might not have complications today, but could face blindness, heart attacks, kidney failure and amputations in the future. Those patients “need a better tool now,” he said. Abbott soon followed with FDA over-the-counter clearances for its Lingo biosensor and Libre Rio sensor, the latter of which is indicated for type 2 patients who aren’t on insulin and manage diabetes through lifestyle modifications. Dexcom EVP and Chief Operating Officer Jake Leach said in an interview that his company is taking a two-pronged approach toward type 2 diabetes: make products easier to use, and generate clinical evidence to support the expansion. “You have to generate that evidence to show the benefits that CGM can provide,” he said. “There were questions in the beginning, like will someone with type 2 diabetes benefit from CGM like those with type 1? We were very confident they would, but we had to generate the evidence and that evidence generation continues. … The addressable market is very large. It’s our job to figure out how to get people the CGMs that they need.” What to watch for in the type 2 market Insulet and Tandem have launched their type 2 AIDs and Medtronic’s MiniMed 780G submission is expected to reach the FDA soon. Medtronic and Tandem are also developing patch pumps. Senseonics has developed the long-term implantable Eversense E3 CGM for both type 1 and type 2. The implant offers 365 days of continuous glucose monitoring and has an integrated CGM (iCGM) indication, meaning it can pair with AID systems in the future. Dexcom is working on a next-gen CGM that will be 50% smaller, packing more powerful electronics into a thinner, lower-circumference form factor. “The more powerful electronics means it can handle three different readings at the same time,” Sayer said, noting the device was in feasibility studies when we interviewed him in January. “It’ll be a while — like a couple years — before that is through all of our work process.” And at Insulet, Hollingshead said the team is working on improved algorithms for more automation and enhanced form factors. “People living with diabetes deserve to have better and simpler care,” he said. “That’s where we’re going.”

Newronika—which was spun out of the University of Milan and Fondazione IRCCS Ca\' Granda Ospedale Maggiore Policlinico Hospital—said it aims to launch AlphaDBS in Europe this year. \n The Italian neuromodulation startup Newronika has secured a European approval for its closed-loop, adaptive implant for people with Parkinson’s disease, offering a deep-brain stimulation approach to help control its symptoms.The company’s AlphaDBS system continuously adjusts its output based on real-time brain signals, instead of the conventional therapy of fixed stimulation doses. The personalized approach aims to reduce side effects as well as the need for device reprogrammings and updates by neurologists. “The CE Mark approval of AlphaDBS is a defining moment for Newronika and for the field of deep brain stimulation,” the company’s co-founder and CEO, Lorenzo Rossi, said in a statement. “This certification validates our vision of bringing truly adaptive neuromodulation to patients. We are excited to bring this technology to market and to set a new standard in the treatment of Parkinson\'s disease.”Newronika—which was spun out of the University of Milan and Fondazione IRCCS Ca\' Granda Ospedale Maggiore Policlinico Hospital—said it aims to launch AlphaDBS in Europe this year. Its greenlight follows up on Medtronic’s CE mark for adaptive deep-brain stimulation, which was obtained in early January. That green light enabled more personalized therapies for patients who have already been implanted with its Percept neurostimulators and BrainSense recording technology—and allowed the medtech giant to roll out closed-loop therapy the same day, essentially as a software update. Medtronic secured an FDA approval shortly thereafter. The company said the approach had spent more than 10 years in development, and that more than 40,000 Percept patients worldwide may be eligible for the therapy.Newronika, meanwhile, recently received a go-ahead from the FDA to conduct a U.S. clinical trial for AlphaDBS. That study will compare adaptive therapy to conventional deep-brain stimulation in patients with advanced Parkinson’s.Last month, the company also raised 13.6 million euros, or about $14.7 million, in a series B financing round. The financing was led by new investor Fondazione ENEA Tech e Biomedical, and joined by existing backers Indaco Venture Partners SGR, Innogest SGR, Wille Finance, TNBT Capital and F3F. In addition, Newronika has received a research grant from the Michael J. Fox Foundation.