Medtronic announces key Affera™ clinical study milestones for Sphere-9™ and Sphere-360™ catheters as global adoption continues

Rhea-AI Summary

Medtronic (NYSE: MDT) reported interim clinical and regulatory milestones for the Affera system and Sphere catheters on April 25, 2026. Key data: 65.5% of VT patients were free from recurrence at six months; FDA granted Breakthrough Device designation for Sphere-9 and approved a U.S. pivotal IDE. Sphere-360 showed 100% lesion durability in left common pulmonary veins subanalysis, has CE Mark (Jan 2026), and a U.S. IDE is enrolling. First patient enrolled in Conquer-AF to study Sphere-9 in repeat AFib ablations.

Positive

• 65.5% freedom from VT recurrence at six months (interim)
• FDA Breakthrough Device designation for Sphere-9
• U.S. pivotal IDE approval for Sphere-9
• Sphere-360 showed 100% lesion durability in left common pulmonary veins
• Sphere-360 received CE Mark in January 2026; U.S. IDE enrolling

Negative

• Sphere-9 is not approved for VT in any geography
• Interim VT result implies ~34.5% experienced recurrence by six months

Market Context

This announcement highlights promising Affera clinical milestones, including 65.5% of VT patients fr...

Analysis

This announcement highlights promising Affera clinical milestones, including 65.5% of VT patients free from recurrence at six months and 100% lesion durability for a Sphere-360 sub-analysis. It extends Medtronic’s track record of building evidence in pulsed field and RF ablation to support broader arrhythmia indications. Historically, similar clinical-trial news has produced modest stock moves. Investors may watch for regulatory decisions, IDE trial progress, and any future debt offerings under the existing S-3ASR shelf as key follow-ups.

Key Figures

VT-free at 6 months: 65.5% Follow-up duration: 6 months Lesion durability: 100% +5 more

8 metrics

VT-free at 6 months 65.5% Patients in Sphere-9 ventricular tachycardia early feasibility study

Follow-up duration 6 months Post-ablation follow-up for Sphere-9 VT study patients

Lesion durability 100% Sphere-360 AFib sub-analysis in patients with left common pulmonary veins

Per-vein durability 98% Previously reported Sphere-360 durability per vein at 75 days

Per-patient durability 93% Previously reported Sphere-360 durability per patient at 75 days

Remapping timepoint 75 days Invasive remapping after initial Sphere-360 AFib procedures

Global team size 95,000+ people Medtronic global workforce mentioned in company overview

Health conditions treated 70 conditions Number of health conditions Medtronic technologies address

Previous Clinical trial Reports

3 past events · Latest: Oct 08 (Positive)

Same Type Pattern 3 events

Date	Event	Sentiment	24h Move	Catalyst
Oct 08	IDE trial initiation	Positive	-0.5%	Launched Embrace Gynecology IDE study for Hugo robotic surgery in hysterectomy.
Apr 26	Trial endpoints met	Positive	-0.1%	Expand URO IDE trial met primary safety and effectiveness endpoints for Hugo RAS.
Sep 27	Durability data update	Positive	+0.8%	PulseSelect PFA system showed excellent lesion durability in real-world AFib setting.

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

Pattern Detected

Recent clinical-trial news for MDT has typically produced modest share moves, with two of three positive updates followed by small declines and one by a small gain.

Recent Company History

This announcement adds to Medtronic’s string of clinical milestones. Prior clinical-trial news included initiating the Embrace Gynecology U.S. IDE study for the Hugo system on Oct 8, 2025, positive Expand URO IDE results with 137 patients on Apr 26, 2025, and strong lesion durability data for the PulseSelect PFA system on Sep 27, 2024. Those updates were generally favorable but produced only small price changes, suggesting incremental rather than transformative reactions to clinical data.

Key Terms

ventricular tachycardia, atrial fibrillation, catheter ablation, breakthrough device designation, +4 more

8 terms

ventricular tachycardia medical

"Interim results highlight six-month outcomes for patients treated with the Sphere-9 catheter for sustained monomorphic ventricular tachycardia (VT)"

A fast, abnormal heartbeat that starts in the heart’s lower chambers and can sharply reduce blood flow, potentially causing dizziness, fainting or, in severe cases, sudden collapse; picture an engine running so fast it loses power. For investors, ventricular tachycardia matters because demand for drugs, devices, diagnostic tests and emergency care tied to this condition affects clinical trial results, regulatory approvals, revenue prospects and legal or safety risks for healthcare companies.

atrial fibrillation medical

"new trial to evaluate a broader population of atrial fibrillation (AFib) patients"

Atrial fibrillation is a common heart rhythm problem in which the heart’s upper chambers quiver instead of delivering steady, strong pumps, like a washing machine on an unbalanced cycle. It matters to investors because it increases use of medications, medical devices, hospital care and long‑term monitoring, drives demand for new treatments and diagnostics, and can affect healthcare costs, regulatory decisions and revenue prospects across drug, device and insurance markets.

catheter ablation medical

"Catheter ablation for VT is an established treatment option; however, outcomes have remained suboptimal"

Catheter ablation is a minimally invasive medical procedure in which a thin, flexible tube is threaded into the heart to destroy tiny areas of tissue that cause abnormal heart rhythms, typically using heat or freezing. Investors watch it because growing use or improved success rates can shift demand for specialized medical devices, hospital procedures and follow-up care, alter treatment costs, and compete with drug or implantable alternatives — like repairing a faulty circuit to restore reliable performance.

breakthrough device designation regulatory

"the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Sphere-9 catheter"

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

pulsed field medical

"dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-definition mapping system"

A pulsed field is a medical technology that uses very short, high-voltage bursts of electricity to alter or destroy cells in a targeted area without relying on heat. Think of it like a camera flash that precisely affects a small spot while leaving surrounding tissue largely intact. For investors, pulsed-field approaches can mean treatments with faster recovery, fewer complications, and distinct regulatory and reimbursement paths that influence commercial potential and competitive positioning.

radiofrequency medical

"dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-definition mapping system"

Radiofrequency is a band of electromagnetic energy, like invisible waves of heat or radio music, used to carry signals and to deliver controlled heating in medical or industrial devices. Investors care because technologies that use these waves—from wireless networks to surgical tools that remove tissue or stop bleeding—can drive product sales, regulatory review, and market value; think of it as a core ingredient that enables certain devices or services to work.

pulsed field ablation medical

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

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.

ce mark regulatory

"The Sphere-360 catheter received CE Mark in January 2026, and the Horizon 360 IDE trial is enrolling"

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.

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• HRS late-breaking data: Interim results highlight six-month outcomes for patients treated with the Sphere-9 catheter for sustained monomorphic ventricular tachycardia (VT)
• Breakthrough device designation granted for use of the Sphere-9 catheter for treatment of VT; U.S. pivotal trial approved by FDA
• New at HRS: data show consistent durability for the Sphere-360 catheter across patient anatomies; Sphere-360 approved in CE Mark geographies
• First patients enrolled in Conquer-AF trial to evaluate the Sphere-9 catheter for repeat atrial fibrillation procedures

GALWAY, Ireland and CHICAGO, April 25, 2026 /PRNewswire/ -- Medtronic plc, (NYSE: MDT), a global leader in healthcare technology, today announced continued momentum for the Affera™ family of technologies for cardiac arrhythmia treatment, including promising data presented at the Heart Rhythm Society (HRS) Annual Meeting and the start of a new trial to evaluate a broader population of atrial fibrillation (AFib) patients. With ongoing positive physician feedback and global commercial expansion, Medtronic continues to invest in clinical research to study the Affera mapping and ablation system for potential new indications.

Results from the ongoing early feasibility study evaluating the Affera mapping and ablation system and the Sphere-9™ catheter for treatment of recurrent sustained monomorphic ventricular tachycardia (VT) after a heart attack were presented as a late-breaking clinical trial. Patients treated at centers across the U.S. were followed for six months post-ablation. Results showed 65.5% of patients remaining free from VT recurrence at six months.¹

VT is a potentially life-threatening arrhythmia that causes the heart to beat abnormally fast. VT patients are treated with medications and often receive life-saving therapies from implanted defibrillators in the form of pacing or shocks.² Catheter ablation for VT is an established treatment option; however, outcomes have remained suboptimal with little ablation tool innovation in recent years. As a result, a significant unmet need exists to improve patient care.^{3, 4}  

In recognition of this critical unmet need, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Sphere-9 catheter for the treatment of VT, providing an expedited regulatory pathway for the technology.

"Physicians urgently need better tools for VT that are safe, effective, and increase procedure efficiency, so it's exciting to see sustained outcomes for ischemic patients treated with the Affera mapping and ablation system and the Sphere-9 catheter after six months," said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. "Moving this research forward to the IDE trial and expanding the patient population to include non-ischemic patients are positive next steps for VT patients."

The Affera mapping and ablation system with the Sphere-9 catheter is an all-in-one, dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-definition mapping system for use in cardiac electrophysiology ablation procedures.

Also at HRS, a new sub-analysis from the Sphere-360™ European study demonstrated positive results related to durability of lesions in AFib procedures in patients with left common pulmonary veins. Results showed 100% lesion durability, highlighting consistency across patients with varied anatomies. Previously reported durability data showed 98% per vein and 93% per patient durability through invasive remapping at 75 days post-ablation. The Sphere-360 catheter is an all-in-one mapping and single-shot pulsed field ablation (PFA) catheter for treatment of paroxysmal AFib that is approved in Europe and investigational in the U.S., with the U.S. IDE trial underway.

Medtronic also announced the first patient enrollment in Conquer-AF, a prospective, multi-center, interventional, non-randomized study to characterize the safety and effectiveness of the Sphere-9 catheter in patients with recurrent paroxysmal or persistent AFib who have previously had an ablation procedure. The study is enrolling patients in the U.S., Europe, and Australia.

"Our robust clinical research program reinforces our commitment to advancing safe, effective, and efficient therapies to help physicians treat a wide range of cardiac arrhythmias and improve patients' lives," said Khaldoun Tarakji, M.D., MPH, vice president, chief medical officer, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. "The encouraging results shown in this VT study underscore the versatility of the Sphere-9 catheter in treating a variety of different arrhythmias and the potential to advance care and outcomes for patients whose disease is often complex. With the Sphere-360 catheter, consistent durability across a wide range of patient anatomies is good news for patients and for physicians' workflow."

The Sphere-9 catheter is approved in multiple geographies including the U.S., Europe, Australia, and Japan. Indications vary by geography. The Sphere-9 catheter is not approved for VT in any geography. The Sphere-360 catheter received CE Mark in January 2026, and the Horizon 360 IDE trial is enrolling patients in the U.S.

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.

1. Reddy VY, et al. Six-month outcomes from the Sphere-9 ventricular tachycardia early feasibility study: Dual-energy lattice-tip mapping and ablation catheter for ventricular tachycardia treatment. Late-Breaking Clinical Trial, Heart Rhythm Society Annual Meeting, April 25, 2026; Chicago IL.
2. Sciria,C. et al. Trends and Outcomes of Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic and Nonischemic Cardiomyopathy. Circ: Arr. and Elec. 2022; vol.15, no. 4.
3. Cronin EM, et al. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias. EP Europace. 2019 Aug 1;21(8):1143-4.
4. Zeppenfeld K, et al. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126.

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) report about Sphere-9 VT results on April 25, 2026?

Interim answer: 65.5% of patients treated with Sphere-9 remained free from VT recurrence at six months. According to the company, this result comes from an early feasibility U.S. study presented as a late-breaking trial at HRS, with follow-up to characterize durability and safety.

Has the FDA taken any regulatory actions for the Sphere-9 catheter (MDT)?

Direct answer: The FDA granted Breakthrough Device designation and approved a U.S. pivotal IDE for Sphere-9. According to the company, the Breakthrough status provides an expedited pathway while the IDE enables a pivotal trial to evaluate the device in the U.S.

What durability data did Medtronic present for the Sphere-360 catheter (MDT)?

Short answer: A Sphere-360 subanalysis showed 100% lesion durability in left common pulmonary veins. According to the company, prior remapping data reported 98% per vein and 93% per patient durability at 75 days, supporting consistency across varied anatomies.

Is Sphere-360 approved and available outside the U.S. (MDT)?

Direct answer: Yes, Sphere-360 received CE Mark in January 2026 and is commercially available in CE geographies. According to the company, the Horizon 360 IDE trial is simultaneously enrolling patients in the U.S. for investigational use there.

What is the Conquer-AF study announcement for Sphere-9 by Medtronic (MDT)?

Direct answer: Medtronic enrolled the first patient in Conquer-AF to study Sphere-9 in repeat AFib procedures. According to the company, Conquer-AF is a prospective, multi-center, non-randomized study enrolling in the U.S., Europe, and Australia to assess safety and effectiveness.