Medtronic announces expanded CE Mark indication for Affera™ Mapping and Ablation System and Sphere-9™ Catheter for treatment of ventricular arrhythmias

Rhea-AI Summary

Medtronic (NYSE: MDT) announced an expanded CE Mark indication for its Affera™ Mapping and Ablation System with Sphere-9™ Catheter to treat ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVCs). Sphere-9 is the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter CE marked for ventricular ablation.

The FDA has granted Breakthrough Device Designation for Sphere-9 for ventricular arrhythmias, providing an expedited U.S. regulatory pathway. Medtronic also reported that the Sphere VT pivotal trial, designed to support future U.S. approval for VT treatment, is now enrolling patients.

Positive

• Expanded CE Mark indication for Affera System and Sphere-9 to treat ventricular arrhythmias, including VT and PVCs
• Sphere-9 is the first CE-marked all-in-one mapping and ablation, large-tip focal, dual-energy catheter for ventricular ablation
• FDA granted Breakthrough Device Designation for Sphere-9 in ventricular arrhythmias, enabling expedited U.S. regulatory review
• Sphere VT pivotal trial now enrolling to evaluate Sphere-9 for VT and support potential future U.S. approval

Negative

• None.

Market Context

MDT's historical record included a 5.69% 24-hour move after June 3 portfolio news, adding a company-...

Analysis

MDT's historical record included a 5.69% 24-hour move after June 3 portfolio news, adding a company-specific comparator. Current context also showed Net Selling insider activity and an effective S-3ASR debt shelf for debt securities. The U.S. pivotal trial's enrollment and future approval path remain key watchpoints.

Key Figures

Employees: 95,000+ people Countries: 150 countries Health conditions: 70 health conditions +1 more

4 metrics

Employees 95,000+ people Across 150 countries

Countries 150 countries Medtronic global operations

Health conditions 70 health conditions Technologies and therapies address

Lives reached two people every second Medtronic technology statement

Historical Context

5 past events · Latest: Jul 20 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 20	earnings scheduling	Neutral	+0.1%	Announced the Q1 FY27 results reporting date and webcast schedule for investors.
Jul 16	acquisition completion	Positive	+3.8%	Completed the $650 million SPR Therapeutics acquisition and added peripheral nerve stimulation technology.
Jun 12	acquisition completion	Positive	-0.2%	Completed the $550 million Scientia Vascular acquisition to expand neurovascular access device capabilities.
Jun 03	regulatory filings	Positive	+5.7%	Submitted 510(k) filings and received clearance supporting Hugo robotic surgery system expansion.
Jun 03	strategic investments	Positive	+5.7%	Announced investments in Beluga Medical and CardioACC supporting Affera portfolio expansion.

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

Pattern Detected

MDT historically aligned with positive company announcements in three of four comparable recent events, while one acquisition announcement diverged.

Key Terms

ce mark, ventricular tachycardia, premature ventricular complexes, breakthrough device designation, +2 more

6 terms

ce mark regulatory

"announced an expanded CE Mark indication for the Affera™ Mapping and Ablation System"

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.

ventricular tachycardia medical

"to treat ventricular arrhythmias, including 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.

premature ventricular complexes medical

"including ventricular tachycardia (VT) and premature ventricular complexes (PVCs)"

Extra heartbeats that start in the heart’s lower chambers (ventricles) and interrupt the normal beat-to-beat rhythm, often felt as a skipped beat, flutter or brief thump. They matter to investors because they show up as safety or efficacy signals in clinical trials, device testing, and medical reports; frequency or severity can influence regulatory reviews, trial results, labeling and market perception—like a hiccup in a product’s performance record.

breakthrough device designation regulatory

"the 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 technical

"dual-energy pulsed field (PF) and radiofrequency (RF) ablation"

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 technical

"dual-energy pulsed field (PF) and radiofrequency (RF) ablation"

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.

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Sphere-9 all-in-one mapping and ablation, large-tip focal, dual energy catheter first to be CE Marked for ventricular ablation

New indication marks important milestone for ventricular arrhythmia patients as positive physician sentiment and global expansion for Sphere‑9 continue

Sphere VT U.S. pivotal trial enrollment underway

GALWAY, Ireland, Aug. 6, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced an expanded CE Mark indication for the Affera™ Mapping and Ablation System with Sphere-9™ Catheter to treat ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVCs). The Sphere-9 catheter is the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter CE marked for ventricular ablation.

"This milestone is a major step forward as we continue to expand the footprint of the Affera technology to more physicians and patients," said Rebecca Seidel, president of the Electrophysiology Therapies business at Medtronic. "Indication expansion to include ventricular arrhythmias unlocks another fast-growing market opportunity to keep building on our momentum, powered by the versatility, safety and efficiency of the Sphere-9 catheter."

Additionally, in recognition of the critical unmet need for ventricular arrhythmia treatments, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Sphere-9 catheter for the treatment of ventricular arrhythmias, which provides an expedited regulatory pathway for the technology in this patient population. The Sphere VT pivotal trial to evaluate Sphere-9 for the treatment of VT and support future approval in the US is now enrolling patients.

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

"Physicians have long needed better tools for ventricular arrhythmias, and we're proud to deliver a technology that addresses this unmet need and moves the needle on patient care," 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 unique features of Sphere-9, including a single catheter to map and ablate using radiofrequency or pulsed field energy and a large footprint, make it an excellent tool for a variety of arrhythmias, including those that may be challenging to treat."

About Ventricular Arrhythmias
VT is a potentially life-threatening arrhythmia that causes the heart to beat abnormally fast.¹ Unlike atrial fibrillation, VT affects the lower chamber of the heart and often presents after a heart attack or together with other advanced heart diseases.^1,2 VT patients are often treated with medications and may receive life-saving therapies from implanted defibrillators in the form of pacing or shocks.¹ Catheter ablation for VT is an established treatment option, but outcomes have remained suboptimal² with little ablation tool innovation in recent years. As a result, a significant unmet need exists to improve patient care.³

PVCs are extra or early heartbeats that start in the heart's lower chambers (ventricles), briefly disrupting normal rhythm and potentially causing a flutter-like feeling in the chest.⁴

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 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 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. 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.
2. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias.
3. Cheung, J, et al. Outcomes, Costs, and 30-Day Readmissions After Catheter Ablation of Myocardial Infarct–Associated Ventricular Tachycardia in the Real World: Nationwide Readmissions Database 2010 to 2015. Circ: Arr. and Elec. 2018; vol. 11, issue 11.
4. American Heart Association, "Premature Contractions: PACs and PVCs." https://www.heart.org/en/health-topics/arrhythmia/about-arrhythmia/premature-contractions-pacs-and-pvcs

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 Affera and Sphere-9 system on August 6, 2026?

Medtronic announced an expanded CE Mark indication for its Affera Mapping and Ablation System with Sphere-9 Catheter to treat ventricular arrhythmias. According to Medtronic, this includes ventricular tachycardia (VT) and premature ventricular complexes (PVCs), broadening eligible patients in CE Mark regions.

What is the significance of the CE Mark expansion for Medtronic’s Sphere-9 catheter (MDT)?

The CE Mark expansion allows Sphere-9 to be used for ventricular arrhythmias, including VT and PVCs. According to Medtronic, Sphere-9 is the first CE-marked all-in-one mapping and ablation, large-tip focal, dual-energy catheter specifically indicated for ventricular ablation.

Did the FDA grant Breakthrough Device Designation for Medtronic’s Sphere-9 catheter for VT (MDT)?

Yes, the FDA granted Breakthrough Device Designation for the Sphere-9 catheter for treating ventricular arrhythmias. According to Medtronic, this designation provides an expedited regulatory pathway for Sphere-9 in this high-need patient population in the United States.

What is the Sphere VT pivotal trial mentioned by Medtronic (MDT) and what is its purpose?

The Sphere VT pivotal trial is a clinical study evaluating Sphere-9 for treating ventricular tachycardia. According to Medtronic, the trial is now enrolling patients and is intended to support potential future U.S. approval of the Sphere-9 catheter for VT treatment.

How does Medtronic describe the Sphere-9 catheter’s technology and capabilities?

Sphere-9 is described as an all-in-one, dual-energy pulsed field and radiofrequency ablation catheter with high-definition mapping. According to Medtronic, its single-catheter approach and large footprint are designed to address complex arrhythmias, including ventricular arrhythmias that can be challenging to treat.

Which ventricular arrhythmias can Medtronic’s Affera System with Sphere-9 now treat under its expanded CE Mark?

Under the expanded CE Mark, the system can treat ventricular arrhythmias including ventricular tachycardia (VT) and premature ventricular complexes (PVCs). According to Medtronic, this indication broadens its use beyond prior applications to address a significant unmet clinical need.