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Medtronic plc (MDT) is a global leader in medical technology, developing innovative healthcare solutions that address chronic diseases and complex conditions. This dedicated news hub provides investors and professionals with timely updates on the company's strategic initiatives, regulatory milestones, and technological breakthroughs.
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Medtronic (NYSE: MDT) announced that the U.S. Centers for Medicare & Medicaid Services finalized a National Coverage Determination (NCD) for renal denervation on Oct. 28, 2025, extending Medicare coverage to qualifying patients for the Symplicity Spyral™ RDN system (the Symplicity blood pressure procedure) to treat uncontrolled hypertension.
The Symplicity Spyral system was approved by the FDA in November 2023, is available in nearly 80 countries, and is positioned by the company as a commercial growth driver as adoption expands across major U.S. hypertension centers and integrated delivery networks.
Medtronic (NYSE: MDT) reported 3‑year SPYRAL HTN‑ON MED results showing sustained blood pressure reductions after Symplicity Spyral renal denervation (RDN) versus sham in patients on antihypertensive medications.
Key 3‑year results: 24‑hr ABPM −14.0 mmHg (RDN) vs −9.3 mmHg (sham; treatment difference −4.7 mmHg; p=0.0028) and office SBP −18.5 mmHg vs −11.7 mmHg (treatment difference −7.4 mmHg; p=0.0002). No renal artery stenosis >70% was observed through three years.
The data were presented at TCT 2025; the Symplicity system is marketed in nearly 80 countries.
Medtronic (NYSE: MDT) announced that BrainSense Adaptive Deep Brain Stimulation (aDBS) was named a 2025 TIME Best Inventions. The sensing-enabled Percept neurostimulator with BrainSense personalizes Parkinson's therapy by adjusting stimulation in real time.
Medtronic said it received both CE Mark and U.S. FDA approval for BrainSense aDBS earlier in 2025, published pivotal results in JAMA Neurology (ADAPT-PD) showing clinical effectiveness, and reported that more than 1,000 patients worldwide have received adaptive therapy.
Medtronic (NYSE: MDT) launched the Embrace Gynecology U.S. IDE clinical study to evaluate the Hugo™ robotic-assisted surgery system for hysterectomy procedures, with enrollment underway and up to 70 patients planned across up to 5 U.S. hospitals. The first total hysterectomy procedures were completed at AHN West Penn Hospital in Pittsburgh on Oct. 8, 2025. Embrace Gynecology is prospective and includes radical, modified radical, and total hysterectomies, inclusive of malignancy cases. This becomes the third U.S. IDE for Hugo RAS after Expand URO and Enable Hernia Repair, both of which met primary safety and effectiveness endpoints. The company notes Hugo RAS is in clinical use in 30+ countries and is CE marked in the EU; in the U.S. the device remains investigational.
Medtronic plc (NYSE: MDT) has announced the successful closing of a public offering through its subsidiary Medtronic, Inc., consisting of €1.5 billion in senior notes. The offering includes €750 million of 2.950% senior notes due 2030 and €750 million of 4.200% senior notes due 2045.
The company raised net proceeds of approximately €1.49 billion after deducting underwriting discounts and expenses. These funds will be used to repay Medtronic Luxco's existing 0.000% Senior Notes and 2.625% Senior Notes, both due in 2025. Deutsche Bank AG, London Branch and Goldman Sachs & Co. LLC served as joint book-running managers for the offering.
Medtronic (NYSE:MDT) has received FDA approval for its Altaviva™ device, a minimally invasive implantable tibial neuromodulation (ITNM) therapy for treating urge urinary incontinence. The device, implanted near the ankle without sedation or imaging, helps restore bladder-brain communication through electrical impulses to the tibial nerve.
The Altaviva device features a 15-year battery life, automatic therapy delivery, and MRI compatibility. It is designed to address a significant market, with 16 million Americans affected by urge urinary incontinence. This approval positions Medtronic as the only company offering a complete portfolio of neuromodulation therapies for bladder control issues.
Medtronic (NYSE:MDT) has announced the pricing of €1.5 billion in senior notes through its subsidiary Medtronic, Inc. The offering consists of €750 million of 2.950% senior notes due 2030 and €750 million of 4.200% senior notes due 2045.
The notes will be fully guaranteed by Medtronic plc and Medtronic Global Holdings S.C.A. The proceeds will be used to repay Medtronic Luxco's existing notes: the 0.000% Senior Notes due 2025 and 2.625% Senior Notes due 2025. The offering is expected to close on September 29, 2025, with Deutsche Bank AG and Goldman Sachs serving as joint book-running managers.
Medtronic (NYSE:MDT) has launched ELEVATE-HFpEF, a global pivotal study investigating a novel cardiac pacing treatment for patients with Heart Failure with preserved Ejection Fraction (HFpEF). The study will evaluate whether personalized elevated pacing rates using conduction system pacing can improve outcomes for HFpEF patients.
The trial will enroll up to 700 participants across multiple regions, using Medtronic's commercially available pacemaker and SelectSecure™ MRI SureScan™ Model 3830 pacing leads. The study targets HFpEF, which affects 32 million people worldwide and represents approximately 50% of heart failure cases. Participants will be followed for one year to assess the efficacy and safety of this investigative treatment.
Medtronic (NYSE:MDT) announced positive results from the Enable Hernia Repair clinical study evaluating their Hugo™ robotic-assisted surgery (RAS) system. The study, involving 193 patients, is the first-ever IDE clinical study for robotic-assisted hernia surgery in the U.S.
The study achieved remarkable results, with a 100% surgical success rate, exceeding the 85% performance goal. Safety endpoints were met with a 0.0% surgical site event rate for inguinal repairs and 2.1% for ventral repairs, both significantly below the 30% threshold. Mean hospital stays were brief at 4.7 hours for inguinal and 6.7 hours for ventral procedures.
The Hugo RAS system is currently available in 30+ countries across five continents, with FDA review ongoing for urology indication and planned expansions into hernia repair and gynecology.
Medtronic (NYSE:MDT) announced two significant FDA milestones for its MiniMed™ 780G system: clearance of the SmartGuard™ algorithm for integration with Abbott's Instinct sensor in type 1 diabetes, and approval for use in adults with type 2 diabetes.
The integration with Abbott's Instinct sensor, the world's smallest and thinnest integrated CGM with a 15-day wear time, will be available after compliance documentation completion. In clinical trials for type 2 diabetes patients, the system demonstrated impressive results, including a 0.7% reduction in HbA1c and increased Time in Range to 81% from 72%.
The MiniMed™ 780G becomes the first and only automated insulin delivery system with Meal Detection™ technology available for type 2 diabetes patients, marking a significant advancement in diabetes management technology.