Affera™ momentum continues as Medtronic announces CE Mark in Europe and U.S. IDE first cases for Sphere-360™ PFA catheter to treat paroxysmal atrial fibrillation

Rhea-AI Summary

Medtronic (NYSE:MDT) announced two milestones for the Affera Sphere-360 pulsed field ablation (PFA) catheter: CE Mark in Europe and completion of first cases in the U.S. Horizon 360 IDE pivotal trial on Jan 23, 2026. The Sphere-360 is a rotation-free, all-in-one mapping and single-shot PFA catheter that adapts to pulmonary vein anatomy, provides real-time local impedance, and integrates with the Affera mapping and ablation system. A prospective European single-arm study presented one-year data showing efficacy, safety, and durability that supported CE Mark. The Horizon 360 IDE will evaluate safety and effectiveness for treating paroxysmal atrial fibrillation in U.S. centers.

Positive

• Received CE Mark in Europe for Sphere-360 catheter
• European single-arm study showed 1-year efficacy, safety, durability
• Completed first cases to start the Horizon 360 IDE pivotal U.S. trial
• All-in-one design enables single transseptal puncture and no catheter exchange
• Adjustable 34 mm lattice delivers circumferential lesions without rotation

Negative

• U.S. approval pending; only IDE first cases completed so far
• Clinical evidence cited is from a single-arm European study, not randomized

News Market Reaction – MDT

-0.45%

-0.45% Session close to close

In the Jan 23 session, MDT declined 0.45%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds another milestone to Medtronic’s Affera platform, combining CE Mark for the S...

Analysis

This announcement adds another milestone to Medtronic’s Affera platform, combining CE Mark for the Sphere-360™ PFA catheter in Europe with first cases in the Horizon 360 IDE study in the U.S. It reinforces the company’s focus on pulsed field ablation and integrated mapping systems for paroxysmal atrial fibrillation. In context of recent FDA clearances, diabetes pipeline moves, and ongoing dividends of $0.71 per share, investors may monitor future clinical data, adoption trends, and regulatory progress for this catheter system.

Key Figures

Lattice size: 34 mm lattice Sheath size: 10 French

2 metrics

Lattice size 34 mm lattice Sphere-360 catheter lesion delivery area

Sheath size 10 French FlexCath Contour deflectable sheath compatibility

Historical Context

5 past events · Latest: Jan 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jan 12	Regulatory clearance	Positive	-0.6%	FDA 510(k) clearance for MiniMed Go Smart MDI system in U.S. market.
Jan 07	Clinical data update	Positive	-0.5%	Real-world MiniMed 780G data showing ADA time-in-range goals even with missed boluses.
Jan 05	Conference appearance	Neutral	+3.0%	CEO and CFO presentation and Q&A at J.P. Morgan Healthcare Conference.
Dec 19	Business IPO plan	Neutral	-0.9%	Filing of Form S-1 for proposed IPO of Diabetes business MiniMed.
Dec 04	Dividend declaration	Positive	-0.6%	Announcement of $0.71 per share cash dividend for Q3 FY26.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent history shows MDT often trading flat to down on positive or neutral news, with only the J.P. Morgan conference headline coinciding with a notably positive move.

Recent Company History

Over the past few months, Medtronic has reported a series of constructive updates: FDA clearance for the MiniMed Go™ Smart MDI system, strong real-world MiniMed 780G data, an announced IPO filing for the Diabetes (MiniMed) business, and continued dividend payments of $0.71 per share for Q3 FY26. Most of these headlines saw modest negative price reactions over the next day, except the J.P. Morgan Healthcare Conference appearance, which aligned with a 3.03% gain. Today’s Affera Sphere-360™ CE Mark and U.S. IDE first cases extend this cadence of product and pipeline milestones.

Key Terms

pulsed field ablation, paroxysmal atrial fibrillation, ce mark, ide pivotal trial, +3 more

7 terms

pulsed field ablation medical

"single-shot pulsed field ablation (PFA) catheter for treatment of paroxysmal"

Pulsed field ablation is a heart procedure that uses very short, high-voltage electrical pulses to selectively disrupt abnormal heart tissue that causes irregular rhythms, rather than heating or freezing it. For investors, it matters because this approach can shorten procedure times, reduce damage to nearby structures, and potentially lower complication rates compared with traditional thermal methods, which can affect device adoption, hospital costs, and market demand for treatment tools.

paroxysmal atrial fibrillation medical

"pulsed field ablation (PFA) catheter for treatment of paroxysmal atrial fibrillation"

A heart rhythm problem in which the heart’s upper chambers suddenly start beating fast and irregularly in episodes that begin and stop on their own, typically lasting minutes to days. Like a car that occasionally skids on a patch of ice before regaining control, these episodes raise risks of stroke, hospital visits and ongoing treatment needs, so they matter to investors because they shape demand for drugs, devices, clinical trials, regulatory decisions and healthcare costs tied to companies in this market.

ce mark regulatory

"two major milestones ... CE Mark in Europe and the completion of first cases"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

ide pivotal trial regulatory

"first cases in the Horizon 360 IDE pivotal trial in the United States."

An IDE pivotal trial is the main, large-scale clinical study run under an Investigational Device Exemption (IDE) that regulators require to prove a medical device is safe and works as intended. Think of it as the product’s final exam or big dress rehearsal before approval: positive results clear the way for marketing and sales, while negative or uncertain results raise development delays, regulatory obstacles and financial risk for investors.

pulmonary veins medical

"accommodates anatomical variations in pulmonary veins. Seamlessly integrated"

Pulmonary veins are the vessels that carry oxygen-rich blood from the lungs back into the heart so it can be pumped to the rest of the body. Investors watch them because diseases, procedures, or devices affecting these veins can drive clinical trial results, regulatory approvals, treatment costs, and market demand for medical products—think of them as the return pipes from a filter to a pump: if they fail or are altered, the whole system is impacted.

transseptal puncture medical

"mapping, and ablation with a single transseptal puncture and zero catheter exchange"

Transseptal puncture is a medical procedure where a doctor creates a small opening through the thin wall that separates the two upper chambers of the heart to reach the left side for treatment. Think of it as making a tiny doorway between two rooms so tools can access a hard-to-reach area. For investors, it matters because the technique, specialized devices, training and safety outcomes influence demand, regulatory approval, procedure volumes and the commercial prospects of companies supplying related technologies.

impedance technical

"Real-time local impedance information to assess catheter proximity to tissue"

Impedance is the total opposition a device or circuit offers to alternating electrical current, combining resistance and frequency-dependent effects; think of it like how a plumbing system resists water flow at different speeds. Investors care because impedance affects product performance, safety, reliability and regulatory acceptance for electronic and medical devices—variations can signal manufacturing issues, wear or design flaws that may lead to recalls, warranty costs, or lost sales.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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First-of-its-kind, rotation-free single-shot PFA catheter supported by strong safety and efficacy data adds to the groundbreaking Affera family of technologies in Europe

Successful completion of first cases at multiple sites kicks off Horizon 360 IDE pivotal trial in the United States

GALWAY, Ireland, Jan. 23, 2026 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced two major milestones for the Affera™ Sphere-360™ catheter, a first-of-its-kind, all-in-one mapping and single-shot pulsed field ablation (PFA) catheter for treatment of paroxysmal atrial fibrillation (AFib): CE Mark in Europe and the completion of first cases in the Horizon 360 IDE pivotal trial in the United States.

The Sphere-360 catheter was designed in response to physician feedback expressing the need for a simple, differentiated workflow and predictable outcomes using a single catheter that accommodates anatomical variations in pulmonary veins. Seamlessly integrated with the Affera mapping and ablation system, the catheter offers an adjustable configuration lattice design that conforms to the shape of the veins and allows energy delivery without the need to rotate the catheter in each position.

The Affera mapping and ablation system and the Sphere-9™ all-in-one mapping and ablation catheter have been rapidly adopted by physicians in multiple geographies for their excellent safety and durability profile.

"The Sphere-360 catheter offers an excellent balance between ease of use and consistency in outcomes. Its design conforms to the pulmonary vein in a unique way that delivers consistent, effective and durable lesions for AFib patients, without any rotation of the catheter," said Tobias Reichlin, M.D., Director of Electrophysiology at Inselspital University Hospital in Bern, Switzerland. "With the full integration into the Affera mapping system, it's an exciting step forward for patient care in Europe."

Additional benefits of Sphere-360 include:

• Delivers circumferential, consistent lesions from the entire 34 mm lattice without catheter rotation, enhancing workflow efficiency
• Adapts to the vein by adjusting the shape of the conformable lattice to the patient's anatomy
• All-in-one catheter for navigation, mapping, and ablation with a single transseptal puncture and zero catheter exchange
• Real-time local impedance information to assess catheter proximity to tissue
• Easy access to pulmonary veins with enhanced stability through its over-the-wire design
• Compatible with FlexCath Contour™ 10 French deflectable sheath designed for easy catheter positioning

"Advances in electrophysiology over the past several years are having a significant impact on care for arrhythmia patients, and Affera has been a key part of that impact," said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. "Now with Sphere-360, we have a new and differentiated single-shot PFA catheter with the potential to deliver the next phase of innovation. It's an exciting time for physicians and patients and we're not slowing down."

Results from the Sphere-360 European study at one year were presented at the Heart Rhythm Society Annual Meeting and published in the Heart Rhythm Journal in April 2025. The prospective, single-arm, multi-center trial in European centers demonstrated excellent efficacy, safety, and durability that led to CE Mark.

"The achievement of CE Mark for Sphere-360, as well as the first cases in the U.S. IDE trial, mark two major achievements in our effort to deliver new and better treatments to AFib patients," said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio. "We're committed to leading in PFA and bringing meaningful innovation at a regular cadence."

The Horizon 360 IDE study is a prospective, single-arm clinical study at centers across the U.S. The study will evaluate the safety and effectiveness of the Sphere-360 catheter with the Affera mapping and ablation system for treating paroxysmal AFib.

About Medtronic PFA
Medtronic was the first company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 35 countries.

Sphere-9™ is the only all-in-one, dual energy mapping and ablation catheter for treatment of persistent AFib and concomitant CTI-dependent atrial flutter. The Affera system, together with the Sphere-9 catheter, enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can be used with an 8.5Fr sheath. Affera is approved in the U.S., Europe, Australia and New Zealand and Japan, with global expansion ongoing. The Affera Mapping and Ablation System with Sphere-9 Catheter received CE Mark in March 2023 and U.S. Food and Drug Administration (FDA) approval in October 2024.

The Sphere-360 catheter is approved in Europe and investigational in the United States. For more information on the Affera system, the Sphere-9 catheter and the Sphere-360 catheter, visit Medtronic.com.

About Atrial Fibrillation
AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide¹. AFib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases^2-5.

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 more than 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, visit www.Medtronic.com 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.

References

1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
4. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ingrid Goldberg
Investor Relations
+1-763-505-2696

 

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SOURCE Medtronic plc

FAQ

What did Medtronic (MDT) announce about the Sphere-360 catheter on January 23, 2026?

Medtronic announced a CE Mark in Europe and completion of first cases in the U.S. Horizon 360 IDE pivotal trial.

How did the Sphere-360 perform in European clinical data for AFib?

A prospective, single-arm European study presented 1-year results showing efficacy, safety, and durability, supporting CE Mark.

What is the design advantage of the Sphere-360 PFA catheter for paroxysmal AFib?

Sphere-360 is an all-in-one, rotation-free 34 mm lattice catheter that adapts to vein anatomy and allows mapping and ablation with one transseptal puncture.

Does the Sphere-360 have U.S. regulatory approval as of Jan 23, 2026?

No; Sphere-360 has completed first cases in the Horizon 360 IDE study but U.S. market approval is pending IDE trial results and regulatory review.

What will the Horizon 360 IDE study evaluate for the Sphere-360 catheter?

The study will evaluate the safety and effectiveness of Sphere-360 with the Affera system for treating paroxysmal atrial fibrillation in U.S. centers.