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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 plc (NYSE: MDT) announced FDA expanded approval for its Arctic Front™ Family of Cardiac Cryoablation Catheters as an initial rhythm control strategy for recurrent symptomatic paroxysmal atrial fibrillation. This is the first approval allowing cryoablation before antiarrhythmic drug therapy failure. Results from the STOP AF First study showed cryoablation significantly outperforms drug therapy in preventing arrhythmia recurrence. Nearly 60 million people are affected by atrial fibrillation globally, with this new option providing a safer, effective alternative to traditional treatments.
Medtronic plc (NYSE: MDT) has received FDA approval for its Vanta™ neurostimulator, a recharge-free implantable device with a lifespan of up to 11 years, nearly doubling that of competitive devices. It features AdaptiveStim™ technology, which adjusts to patient movement, offering personalized pain relief. The device is designed for broad MRI compatibility, crucial for the 82% of spinal cord stimulation patients requiring MRI scans within five years. The Vanta is 20% smaller than its predecessor and includes data insights via Snapshot™ reporting.
Medtronic plc (NYSE:MDT) announced the STROKE AF trial results showing the Reveal LINQ™ Insertable Cardiac Monitor (ICM) significantly outperformed standard care in detecting atrial fibrillation (AF) in stroke patients. The study involved 496 patients, revealing AF detection rates of 12.1% in the ICM group versus 1.8% in standard care. The findings underscore the importance of long-term monitoring for stroke prevention, as 78% of AF patients could have been missed with traditional monitoring. The results, published in JAMA, highlight the potential for ICMs to transform secondary stroke prevention practices.
Medtronic plc (NYSE:MDT) announced FDA approval and first implants of the SenSight™ Directional Lead System for Deep Brain Stimulation (DBS) therapy. This innovative system uniquely combines directionality with sensing abilities, allowing for precise treatment of movement disorders like Parkinson's disease. SenSight is designed to enhance patient comfort, enable personalized therapy, and provide valuable brain activity data. Following its initial U.S. implants at the University of Florida, a full U.S. launch is imminent. The product has also received CE Mark for Western Europe earlier this year.
Medtronic (NYSE:MDT) has received FDA clearance for its patient-specific UNiD™ Rods, enhancing the functionality of its CD Horizon™ Solera™ Voyager™ and Infinity™ OCT spinal systems. These rods, tailored using AI-driven pre-operative surgical plans, aim to reduce malalignment risks during spinal surgeries. The first successful surgery using the UNiD Rods was performed in Indianapolis, highlighting their potential to improve surgical precision and outcomes. Medtronic emphasizes the integration of AI, robotics, and personalized implants to revolutionize spine care.
Medtronic plc (NYSE:MDT) announced the cessation of the HVAD™ System distribution due to a rise in neurological adverse events and mortality rates compared to other devices. This decision affects approximately 4,000 existing patients. Medtronic is launching a support program for these patients and their caregivers while coordinating with global regulators. The financial impact is anticipated to be neutral to slightly accretive to fiscal year 2022 non-GAAP diluted EPS, despite the HVAD generating $141 million in FY 2021 revenue.
Medtronic plc (NYSE:MDT) announced positive real-world outcomes for its MiniMed™ 780G insulin pump system, evaluating 4,120 users across Europe. The system demonstrated a 76.2% average Time in Range and maintained 94% of users in Advanced Hybrid Closed Loop mode. A smaller cohort of 812 individuals showed a 12.1% increase in Time in Range and a 0.4% percentage drop in GMI after using the system. Available in 30 countries, it is currently under FDA review for U.S. approval.
Medtronic (NYSE:MDT) will virtually participate in the 14th International Conference on Advanced Technologies & Treatments for Diabetes from June 2-5, 2021. The company will present significant clinical data on its MiniMed™ 780G System and Continuous Glucose Monitoring Systems, showcasing cost-effectiveness and real-world outcomes. Key presentations include the performance of the MiniMed™ 780G system in pediatric and adult trials and the effectiveness of the Guardian™ Sensor (3) Continuous Glucose Monitoring System. Medtronic aims to enhance diabetes management through innovative technologies and remote patient support.
Medtronic plc (NYSE:MDT) reported strong financial results for the fourth quarter and fiscal year 2021, with fourth-quarter revenue at $8.188 billion, a 37% increase. The company's earnings per share (EPS) rose to $1.00 GAAP and $1.50 non-GAAP, a 162% and 159% increase, respectively. Fiscal year 2021 revenue reached $30.117 billion, a 4% increase as reported. Medtronic also announced a 9% dividend increase, reflecting confidence in future growth. Guidance for fiscal year 2022 indicates an expected revenue growth of approximately 9% on an organic basis.
Medtronic (NYSE:MDT) has received CE Mark approval for its Guardian™ 4 sensor and InPen™ smart insulin pen, enhancing diabetes management with no fingerstick calibration. These innovations allow integration with the MiniMed™ 780G system or standalone CGM use, expected to launch in Europe in Q2 FY22. The InPen, the first of its kind in Europe, provides real-time glucose readings and insulin dose tracking via a smartphone app. The MiniMed 780G, combined with the Guardian 4, automates insulin delivery adjustments every 5 minutes, reducing user burden significantly.