PF ablation systems

PulseSelect™ pulsed field ablation system

<p>The PulseSelect™ pulsed field ablation (PFA) system enables both mapping and precise lesion delivery using biphasic waveform optimization.</p>

Ordering information
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PulseSelect™ PFA system design and safety features

Unmatched safety1

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 adaptability2,3

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
This is a family shot of the products that make up the PulseSelect™ pulsed field ablation system with callouts.

PulseSelect™ pulsed field ablation (PFA) system + FlexCath Contour™ steerable sheath

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
This is an image of the 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

This is an image of the PulseSelect™ pulsed field ablation catheter tip.

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

This is an image of the side of the 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.

Ordering information

Item number Description
PSCC100 PulseSelect PFA catheter
PSG100 PulseSelect PFA generator

Resources

  1. Verma A, Haines DE, Boersma LV, et al. Pulsed field ablation for the treatment of atrial fibrillation: PULSED AF Pivotal Trial. Circulation. 2023;147(19):1422–1432.

  1. Based on internal test report (D01071310), Formal report for compatibility.
  2. Based on internal test report (D01071316), Characterization report with all additional image.