Medtronic Reports Positive Results for New Affera Pulsed Field Ablation Technologies in AFib Treatment

Medtronic announced promising one-year clinical trial results for its next-generation Sphere-360 pulsed field ablation (PFA) catheter and Sphere-9 dual-energy catheter at the Heart Rhythm Society 2025 Annual Meeting. The Sphere-360 catheter showed an 88% freedom from arrhythmia recurrence rate and a 98% chronic pulmonary vein isolation success rate, with no serious adverse events reported.

Additionally, a sub-analysis of the Sphere Per-AF IDE study demonstrated that the Sphere-9 catheter safely and effectively enables linear ablation in persistent AFib patients. Medtronic plans to begin a U.S. pivotal trial for Sphere-360 later this year. The company continues to expand its electrophysiology leadership with its Affera and PulseSelect PFA systems, aiming to provide more treatment options for atrial fibrillation, which affects over 60 million people worldwide.

Medtronic Advances Abbott CGM Partnership with FDA Submissions

Medtronic has submitted 510(k) applications to the U.S. FDA for clearance of an interoperable insulin pump as part of its ongoing collaboration with Abbott.

Key submissions include:
- MiniMed 780G pump as an Alternate Controller Enabled (ACE) insulin pump
- SmartGuard algorithm as an interoperable automated glycemic controller (iAGC)

The devices are intended for integration with Abbott’s latest continuous glucose monitoring (CGM) platform.

Pending FDA clearance, this system will be sold exclusively by Medtronic and include smart dosing technologies for both automated insulin delivery and multiple daily injections.

Medtronic emphasized the urgency and significance of expanding CGM choices for people with diabetes and aims to bring enhanced system options to market following regulatory approval.

Medtronic Gains FDA Approval for Simplera Sync Sensor for Use with MiniMed 780G Diabetes System

Medtronic announced FDA approval for its new Simplera Sync™ sensor, now compatible with the MiniMed™ 780G insulin pump system. The new sensor is a disposable, all-in-one device that requires no fingersticks with SmartGuard™, no overtape, and features a simple two-step insertion process. It joins Medtronic’s CGM portfolio and offers users more flexibility in managing diabetes.

The MiniMed 780G system includes Meal Detection™ technology and an adaptive algorithm that automatically adjusts insulin every five minutes. It supports glucose targets as low as 100 mg/dL and has demonstrated improved time-in-range outcomes in real-world studies. It is also compatible with a 7-day infusion set, reducing the number of required injections.

A limited U.S. launch of the Simplera Sync sensor is planned for fall 2025. Medtronic continues its mission to simplify diabetes management with cutting-edge technology and user-centered design.

Medtronic Evolut TAVR System Demonstrates Strong Five-Year Results in Low-Risk Aortic Stenosis Patients

Medtronic has announced positive five-year outcomes from its Evolut Low Risk Trial, showing that the Evolut transcatheter aortic valve replacement (TAVR) system continues to deliver durable and effective performance in patients with severe aortic stenosis. Presented at the American College of Cardiology’s annual meeting and published in the *Journal of the American College of Cardiology*, the trial compared Evolut TAVR with traditional surgery in low-risk patients.

In the trial of 1,414 patients, Evolut TAVR showed a slightly lower rate of all-cause mortality or disabling stroke at five years (15.5%) compared to surgery (16.4%). The TAVR group also had a numerically lower rate of cardiovascular mortality and demonstrated better valve performance, with significantly larger effective orifice areas and lower mean gradients.

These results support TAVR as a safe and long-lasting alternative to surgery, especially for younger or lower-risk patients. The findings reinforce recent data from the SMART trial, highlighting Evolut’s superior valve function and lower rates of valve dysfunction. Medtronic’s Evolut system is designed to offer a minimally invasive solution with sustained patient benefits and is part of the company’s broader mission to advance healthcare through innovative technology.

medtronic released two-year results from the smart trial, the largest international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (tavr), demonstrating superior valve performance for the evolut tavr system in patients with small aortic annulus.

the study, presented at the cardiovascular research technologies (crt) 2025 conference in washington, d.c., showed that while composite clinical outcomes such as mortality, disabling stroke, and heart failure hospitalization were comparable between evolut and sapien tavr, evolut exhibited significantly lower rates of bioprosthetic valve dysfunction (bvd).

key findings from the two-year data include:
- five times lower prosthetic valve thrombosis (p=0.0048)
- nine times lower hemodynamic structural valve dysfunction (p<0.001)

dr. howard c. herrmann from the perelman school of medicine emphasized that valve performance is particularly crucial for patients with small aortic annulus, as it impacts long-term outcomes. dr. kendra j. grubb, vice president and chief medical officer for structural heart at medtronic, noted that these results reinforce evolut’s differentiated valve design and its long-term potential.

the smart trial, involving 716 patients across 80 global sites, is the largest randomized control trial to primarily enroll women (87% of participants). the study will continue to follow patients for five years to assess long-term outcomes.

source: [medtronic](https://news.medtronic.com)

The board of directors of Medtronic plc (NYSE: MDT) on Thursday, March 6, 2025, approved the company's cash dividend for the fourth quarter of fiscal year 2025 of $0.70 per ordinary share. This quarterly declaration is consistent with the dividend increase announcement made by the company in May 2024. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 47 consecutive years. The dividend is payable on April 11, 2025, to shareholders of record at the close of business on March 28, 2025.

Medtronic has received U.S. FDA approval for BrainSense Adaptive Deep Brain Stimulation (aDBS), marking the first closed-loop DBS system for Parkinson’s disease. This system dynamically adjusts therapy based on individual brain activity in real time, improving symptom control without manual adjustments. The approval also includes the BrainSense Electrode Identifier, which speeds up DBS programming by 85%.

Developed over a decade, this technology represents the largest commercial launch of brain-computer interface (BCI) technology. The approval follows clinical trials, including the ADAPT-PD study, which demonstrated the benefits of aDBS for managing Parkinson’s symptoms.

BrainSense aDBS and EI are also available in Europe, with U.S. patient programming beginning in select healthcare systems in the coming weeks.

Source: Medtronic, "Medtronic earns U.S. FDA approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's," February 24, 2025.

Medtronic reported financial results for the third quarter of fiscal year 2025, demonstrating continued revenue growth and strong earnings performance. The company generated $8.3 billion in revenue, marking a 2.5% increase as reported and 4.1% on an organic basis. GAAP diluted earnings per share (EPS) rose 2% to $1.01, while non-GAAP diluted EPS increased 7% to $1.39.

The Cardiovascular segment achieved 3.7% revenue growth, driven by strong adoption of pulsed field ablation (PFA) products, with Cardiac Rhythm & Heart Failure revenue increasing 5.1%. The Neuroscience segment grew 4.4%, benefiting from robust demand for neuromodulation devices, including spinal cord stimulators and deep brain stimulators. The Medical Surgical division saw a slight revenue decline of 1.9%, affected by challenges in the stapling segment and changes in U.S. distributor buying patterns. Meanwhile, the Diabetes segment posted 8.4% revenue growth, supported by continued adoption of the MiniMed 780G insulin pump system.

Medtronic reaffirmed its fiscal year 2025 guidance, expecting organic revenue growth between 4.75% and 5% and non-GAAP EPS in the range of $5.44 to $5.50. The company anticipates accelerating both revenue and earnings growth in the fourth quarter, with high-single-digit adjusted EPS growth in the latter half of the fiscal year.

The company also highlighted strategic milestones, including an expansion in the carotid stenting market, a new manufacturing site approval for pulsed field ablation devices, and regulatory progress in renal denervation for hypertension treatment. A video webcast discussing the results is available on Medtronic’s investor relations website.

On January 21, 2025, Medtronic plc announced the appointment of Thierry Pieton as Executive Vice President and Chief Financial Officer (CFO), effective March 3, 2025. Thierry Pieton brings extensive financial expertise, having previously held leadership roles at PricewaterhouseCoopers, General Electric, Nissan Motor Company, and Renault. His compensation package includes an $850,000 base salary, an annual incentive plan with a 110% target of his base salary, and a $2 million long-term incentive plan for fiscal 2025, consisting of performance share units, stock options, and restricted stock units.

Additionally, Mr. Pieton will receive a $3 million cash bonus and a one-time restricted stock unit award valued at $2.5 million to compensate for foregone compensation at his previous employer. Other benefits include relocation assistance, an annual allowance, and eligibility for Medtronic's deferred compensation and health plans. His employment is at-will, with severance and change-in-control protections outlined under the company’s policies.

In the interim, Gary Corona will continue to serve as Interim CFO until Mr. Pieton assumes his role. To recognize his contributions, Mr. Corona received a one-time restricted stock unit grant of $1 million, vesting in full after one year.

This transition marks a significant leadership update for Medtronic, positioning the company for continued growth under Mr. Pieton’s financial stewardship.