Medtronic announces positive results from real-world registries for the Sphere-9™ catheter and PulseSelect™ PFA System at APHRS 2026

The ventricular tachycardia analysis extends the registry evidence beyond atrial fibrillation, with results from 46 patients.

Rhea-AI Summary

Medtronic (MDT) announced real-world registry results for its Sphere-9 catheter and PulseSelect pulsed field ablation system at APHRS 2026.

In 1,050 atrial fibrillation patients, the APEX analysis reported a 1.1% major complication rate. REAL PULSE, involving 1,160 atrial fibrillation patients, reported 100% acute success and a 0.09% acute major complication rate. A separate European APEX analysis of 46 ventricular tachycardia patients reported 87% acute success and estimated six-month freedom from recurrence of 75%. Six major complications occurred in four patients. Sphere-9 is CE marked for ventricular tachycardia but remains investigational and not approved for that use in the United States.

Positive

• Minor pointSphere-9's APEX atrial fibrillation analysis reported a 1.1% major complication rate among 1,050 patients.
• Minor pointAPEX atrial fibrillation patients had no acute kidney injury, severe coronary spasm or phrenic nerve injury.
• Minor pointPulseSelect's REAL PULSE analysis reported 100% acute success among 1,160 atrial fibrillation patients.
• Minor pointREAL PULSE reported a 0.09% acute major complication rate.
• Minor pointSphere-9's ventricular tachycardia analysis reported 87% acute success among 46 patients.
• Minor pointEstimated six-month freedom from ventricular tachycardia recurrence was 75%.

Negative

• Minor pointSphere-9's ventricular tachycardia analysis reported six major complications in four patients.

Key Figures

APEX AFib patients: 1,050 patients Major complication rate: 1.1% Acute success rate: 100% +5 more

APEX AFib patients

1,050 patients

Sphere-9 global registry analysis

Major complication rate

1.1%

APEX registry; Sphere-9 in AFib

Acute success rate

100%

REAL PULSE registry; PulseSelect in AFib

Acute major complication rate

0.09%

REAL PULSE registry; PulseSelect in AFib

VT registry patients

46 patients

European APEX analysis

Acute success

87%

Sphere-9 VT registry analysis

Six-month freedom from VT recurrence

75%

Estimated; Sphere-9 VT registry analysis

Major complications

6 complications in 4 patients

Sphere-9 VT registry analysis

Key Terms

atrial fibrillation, ventricular tachycardia, pulsed field ablation, acute kidney injury, +1 more

5 terms

atrial fibrillation medical

"patients with atrial fibrillation (AFib) and ventricular tachycardia (VT)"

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.

ventricular tachycardia medical

"patients with atrial fibrillation (AFib) and 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.

pulsed field ablation medical

"PulseSelect™ Pulsed Field Ablation (PFA) System"

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.

acute kidney injury medical

"with no acute kidney injury, severe coronary spasm or phrenic nerve injury"

A sudden decline in how well the kidneys remove waste and balance fluids, often developing over hours or days; think of it like an engine that abruptly loses power and can’t filter efficiently. It matters to investors because it can drive higher medical costs, alter clinical trial results, trigger regulatory scrutiny, lead to drug label changes or recalls, and affect revenue and liability for healthcare and life sciences companies.

ischemic cardiomyopathy medical

"in ischemic and non-ischemic cardiomyopathy patients"

Ischemic cardiomyopathy is a condition in which the heart’s main pumping muscle becomes weak because it hasn’t received enough blood over time, usually due to blockages in the arteries that feed the heart. For investors, it matters because it drives demand for treatments, devices and long‑term care, and it influences healthcare costs and the revenue prospects of companies developing drugs, surgeries, implants or diagnostic tools for heart disease—think of the heart as a pump clogged by narrowed fuel lines.

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

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• Global APEX and REAL PULSE Registry analyses report strong safety and procedural outcomes across atrial and ventricular arrhythmias
• Medtronic continues to strengthen its position in cardiac ablation, building on a legacy of innovation in electrophysiology

GALWAY, Ireland, Oct. 22, 2026 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive real-world registry results for the Affera™ Mapping and Ablation System with the Sphere-9™ Catheter and the PulseSelect™ Pulsed Field Ablation (PFA) System. The global registry analyses, presented at the Asia Pacific Heart Rhythm Society (APHRS) 2026 scientific meeting, evaluated prospectively enrolled patients with atrial fibrillation (AFib) and ventricular tachycardia (VT).

"These favorable results reinforce our confidence in the safety and performance of our ablation technologies worldwide. It is very encouraging to see physicians' positive response and real-world evidence that supports effective, safe, and efficient care for patients with a wide range of arrhythmias," said Khaldoun Tarakji, M.D., MPH, Vice President and Chief of Science, Research and Technology, Electrophysiology Therapies at Medtronic.

APEX registry: Sphere-9 real-world outcomes in atrial fibrillation
The APEX global prospective registry analysis included 1,050 patients with AFib treated with the Sphere-9 catheter and Affera Mapping and Ablation System across 28 global sites. The major complication rate was low at 1.1%, with no acute kidney injury, severe coronary spasm or phrenic nerve injury. Major complication rates did not differ significantly between de novo and repeat ablation procedures.

REAL PULSE global registry: PulseSelect real-world safety and performance
The REAL PULSE global prospective registry analysis included 1,160 atrial fibrillation patients treated with the PulseSelect PFA system across 38 global sites. Results were positive, including a 100% acute success rate and a low acute major complication rate of 0.09%.

APEX registry: Expanding evidence in ventricular tachycardia
A separate European APEX registry analysis evaluated use of the Sphere-9 catheter in patients undergoing ablation for VT, demonstrating promising results for the potential of the Sphere-9 catheter and pulsed field ablation in a patient population that can be challenging to treat.

• The analysis included 46 patients with ischemic and non-ischemic sustained VT and demonstrated high acute success (87%) and estimated six-month freedom from VT recurrence (75%).
• There was no significant difference in long-term freedom from arrhythmia recurrence in ischemic and non-ischemic cardiomyopathy patients.
• Six major complications were reported in four patients.

Sphere-9 is CE marked for VT and is investigational only and not approved for VT in the United States. The ventricular ablation indication may not be approved or cleared in all markets.

"As momentum continues to build across our portfolio, it is encouraging to see long-term data support the safety and efficacy profiles of our ablation technologies and the positive impact they are having on procedural workflows," said Felicia Kurz, Vice President and General Manager, Cardiac Ablation Solutions, which is part of the Electrophysiology Therapies business at Medtronic. "We will continue to innovate and strengthen our leadership in cardiac ablation, with a focus on advancing safe, effective and efficient care for patients."

The Medtronic cardiac ablation portfolio offers physicians multiple technologies for patient care, including the Sphere-9 catheter, an all-in-one catheter that combines high-definition mapping with pulsed field and radiofrequency ablation using the Affera mapping and ablation system, and the PulseSelect PFA system, a single-shot solution for pulmonary vein isolation.

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, 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.

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Medtronic's REAL PULSE registry show for PulseSelect?

REAL PULSE reported 100% acute success and a 0.09% acute major complication rate among 1,160 atrial fibrillation patients. The global prospective registry analysis covered 38 sites.

What were Medtronic's Sphere-9 ventricular tachycardia registry results?

The European APEX analysis reported 87% acute success and estimated six-month freedom from ventricular tachycardia recurrence of 75% among 46 patients. Six major complications occurred in four patients. The analysis included patients with ischemic and non-ischemic sustained ventricular tachycardia.

Did Sphere-9 complication rates differ between first and repeat atrial fibrillation ablations in APEX?

Major complication rates did not differ significantly between first-time and repeat ablation procedures in the APEX atrial fibrillation analysis. The prospective registry analysis included 1,050 patients across 28 global sites.

Did Sphere-9 ventricular tachycardia recurrence outcomes differ by cardiomyopathy type?

The European APEX analysis found no significant difference in long-term freedom from arrhythmia recurrence between patients with ischemic and non-ischemic cardiomyopathy.