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PulseSelect™ Pulsed Field Ablation System

PulseSelect™ pulsed field ablation system

For catheter ablation

The PulseSelect™ pulsed field ablation (PFA) system is a cardiac ablation system that enables both mapping and precise lesion delivery using biphasic waveform optimization.

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Family shot of the products that make up the PulseSelect pulsed field ablation system
Alert Indications, Safety, and Warnings

Overview

Setting a new standard in safety. Engineered for efficiency.

The PulseSelect™ PFA system is setting a new standard in safety for paroxysmal and persistent atrial fibrillation ablation supported by 15 years of robust preclinical and clinical evidence. The PulseSelect PFA system offers a differentiated approach to pulsed field ablation that can be implemented across workflows, driving safe, effective, and efficient procedures.1

Features

Discover the PulseSelect™ PFA system design and safety features.

Unmatched safety1,2

Engineered with differentiated safety features from 15 years of PFA research and backed by one of the safest investigational device exemption (IDE) AF ablation trials to date.

Consistent efficiency

Rapid, effective pulmonary vein isolation (PVI)1 through consistent and predictable energy delivery and catheter maneuverability.

Simplified adaptability2

Seamless transition to PFA with freedom to adapt to your preferred workflow.

0:00 / 0:00

PulseSelect™ 
generator

  1. Automatic overcurrent detection for safe energy delivery
  2. R-wave gating for synchronization of energy delivery
  3. Test pulse for proximity detection to phrenic nerve
Family shot of the products that make up the PulseSelect pulsed field ablation system with callouts

PulseSelect™ PFA catheter features

  1. 9 electrodes built to sense, ablate, and pace
  2. 25 mm diameter loop
  3. 9 Fr shaft with bidirectional steering
PulseSelect pulsed field ablation catheter with callouts to highlight specific features

Fixed electrode spacing to produce a reliable field for predictable and consistent contiguous energy delivery.

PulseSelect pulsed field ablation catheter tip

20-degree forward tilt to ensure more consistent uniform tissue contact.

PulseSelect pulsed field ablation catheter tip, showing the 20-degree forward tilt

Trials

PULSED AF clinical trial1

PULSED AF evaluated the safety and effectiveness of the PulseSelect™ PFA system for the treatment of patients with paroxysmal and persistent atrial fibrillation and resulted in one of the lowest safety event rates of any AF ablation IDE trial to date.

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0.7%

(primary safety event rate*)

70%

PAF

(freedom from AF/AFL/AT)

62%

PsAF

(freedom from AF/AFL/AT)

*Total of 13 adverse events measured; resulted in one cerebrovascular accident and one tamponade.

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Reference

1

Verma A, Haines DE, Boersma LV, et al. Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. May 9, 2023;147(19):1422–1432.

2

Medtronic data on file. November 2023.

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