Pioneers in pulsed field ablation

Over 15 years of robust preclinical research in irreversible electroporation (IRE) and clinical application of pulsed field cardiac ablation has yielded PulseSelect™ pulsed field ablation system, the first and only PFA system approved in the U.S. for paroxysmal and persistent AF, and the approval of the Affera™ mapping and ablation system integrated with the only all-in-one dual-energy Sphere-9™ catheter. The Medtronic PFA suite launches a new era in safety and an exciting shift in precision and efficiency in AFib treatment.




Versatile PFA tools to tailor lesion sets

Wide area focal

Wide area focal catheters provide the ability to tailor lesions sets across the anatomy and provide consistent and reliable isolation. 

An all-in-one solution to map, ablate, and validate. Sphere-9™ catheter is the only wide area focal dual-energy PF/RF catheter and is integrated with the Affera™ mapping and ablation system. 


SPHERE Per-AF — superior efficiency compared to traditional RF1

RCT IDE comparing Affera™ mapping and ablation system with Sphere-9™ to Carto®* with Thermocool STSF™*

420 patients | drug-refractory persistent AF | 23 centers | 40+ operators

  • 1.4% primary safety events vs 1% when using STSF
  • 74% primary effectiveness rate
  • 80% effectiveness in more than 10 cases2
  • 25+ minutes saved per procedure


Single shot

Single-shot PFA catheters allow you to achieve wide area circumferential lesions designed with PVI in mind. 

PulseSelect™ pulsed field ablation system is a single-shot over-the-wire PF catheter enabling mapping and precise lesion delivery with the freedom to adapt to your preferred workflow. 


PULSED AF — the safest PFA IDE trial published to date.3

IDE evaluating the safety and effectiveness of the PulseSelect™ PFA system.

300 patients | drug-refractory PAF and PsAF patients | 41 centers | 67 operators


Primary safety events

0.7%


Efficacy

Freedom from AF/AT/AFL



Medtronic PFA history

Began electroporation research for cardiac surgery in 2006

  • First Medtronic PFA patent filed in 2008
  • First Medtronic publication on electroporation for cardiac ablation in 2009

Affera™ Inc. established

Medtronic partners with world-leading experts in electroporation

  • Hemolysis, esophagus, and phrenic nerve impact preclinical research

  • PULSED AF: first PFA IDE trial completed enrollment with PulseSelect™
  • First in human pulsed field cases with Sphere-9™ catheter and Sphere-360™ catheter
  • Medtronic acquires Affera™ mapping and ablation system

  • PULSED AF: safest PFA IDE trial published to date
  • Sphere-9™: first and only all-in-one dual-energy catheter launches in Europe
  • PulseSelect™: first PFA catheter for PAF and PsAF launched globally

  • Sphere-360™: 12-month follow up data published and presented at EHRA
  • SPHERE Per-AF IDE trial: first and only PFA randomized clinical trial in PsAF patients published and presented at HRS

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