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PulseSelect pulsed field ablation system

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

New clinical data!
First published durability data for PulseSelect Presented at APHRS 2024

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.

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.

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.

Education resources on Medtronic Academy

Access detailed product information, including spec sheets, videos, and presentations.

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.

DISCLAIMER

The material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s). Please note that the intended use of a product may vary depending on geographical approvals.

See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.

For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI. If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.

Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.

Medtronic products placed on European markets bear the CE mark and the UKCA mark (if applicable). For any further information, contact your local Medtronic representative.

CE mark 0123