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High materiality8/10

Medtronic Gains Positive APHRS 2026 Real-World Data for Affera Ablation

Oct 22, 2026, 7:20 AM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting

Positive safety/efficacy signals across AFib and VT from real-world registries favor MDT's ablation portfolio; potential uplift in lab adoption and sentiment, offset by US VT indication uncertainties.

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What happened, with direct paths to the underlying reporting

Medtronic unveiled APHRS 2026 registry data showing favorable safety and efficacy for the Affera Sphere-9 mapping system and PulseSelect PFA in AFib and VT. The real-world outcomes—low major complication rates, high acute success, and strong VT recurrence control—reinforce credibility of its ablation platform and could boost clinician adoption ahead of US regulatory or broader market access.

  • Medtronic reports APHRS 2026 registry results for Affera Sphere-9 and PulseSelect.
  • AFib: 1,050 Sphere-9 patients; major complications 1.1%, no AKI or phrenic injury.
  • PulseSelect PFA: 1,160 AFib patients; 100% acute success, major complications 0.09%.
  • VT data: 46 patients; 87% acute success, 75% six-month VT freedom; Sphere-9 VT not US-approved.

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