VARIPULSE™ Catheter
The VARIPULSE™ Platform’s full integration may reduce the need for multiple methods of catheter visualization used in one procedure, creating a streamlined workflow. Both clinical trial and real world evidence demonstrate the safety and value of VARIPULSE™ Platform.
Clinical evidence
The admIRE and inspIRE pivotal trials, along with real world evidence, demonstrates the value of the VARIPULSE™ Catheter.
Zero
85%
admIRE trial n=85. PAF only patients, 1 ablation = 3 applications
63%
30%
Features & benefits
Precise energy delivery
The VARIPULSE™ Platform enables precise energy delivery for initial PVI and identification of gaps when needed, providing physicians with the confidence of an accurate CARTO™ 3 System ecosystem they know.
Pulsed field tag coloring
The VARIPULSE™ Software Module provides automatic 3D visual information about application locations during and after ablation. Pulsed Field (PF) tag coloring provides application feedback during the ablation and the TPI filter removes tags that were not in proximity to tissue at the beginning of ablation.
Tissue proximity indicator
Through pre-clinical studies, Johnson & Johnson MedTech has demonstrated that contact is important to create consistent lesion depth during the ablation. The Tissue Proximity Indicator is designed to visually show the electrodes on the loop that have contact prior, during and after ablation.
Based on internal benchtop data. TR-0042284
Designed for mapping integration
- 35 mm to 25 mm variable loop contraction
- 3 Single Axis Sensor locations designed for accurate visualization on the CARTO™ 3 System
35 mm to 25 mm variable loop contraction
- 10 electrodes that electro-anatomically map, emit pulsed field for ablation and allow pacing per electrode.
- Variable loop size (25mm-35mm) to adjust to fit the patient’s anatomy
Bi-directional deflection
The VARIPULSE™ Catheter is built on a bi-directional, 8 Fr platform compatible with the CARTO VIZIGO™ Bi-Directional Guiding Sheath or similar 8.5 F inner lumen sheath
An integrated system
VARIPULSE™ Platform
TRUPULSE™ Generator
CARTO VIZIGO™ Bi-Directional Guiding Sheath
CARTO™ System Software
Supporting documentation
References
- Almorad A, Sebag FA, Kronborg MB, et al. Acute Safety, Effectiveness and Procedural Workflow for the Pulsed Field Ablation Variable Loop Circular Catheter in AF Procedures: A Prospective, Multicenter, Postmarket Clinical Trial. Presented at ESC 2025; September 1, 2025; Madrid, Spain. Pending formal publication.
- Porterfield C. Real-world safety profile of a multi-electrode variable loop PFA catheter. Presented at KCHRS 2025; August 16, 2025; Kansas City, MO. Pending formal publication.
- Reddy V, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial. Circulation. Published online September 11, 2024. doi: 10.1161/CIRCULATIONAHA.124.070333.
- De Potter T, Grimaldi M, Duytschaever M, et al. Predictors of success for pulmonary vein isolation with pulsed field ablation using a variable loop catheter with 3D mapping integration: complete 12-month outcomes from inspIRE. Circ Arrhythm Electrophysiol. 2024. doi: 10.1161/CIRCEP.123.012667.
Biosense Webster, Inc.’s products with FDA approved/cleared instructions for use to support fluoro alternative workflows when used with the CARTO™ 3 System include the following: THERMOCOOL SMARTTOUCH™ SF Catheter, THERMOCOOL SMARTTOUCH™ Catheter, VARIPULSE™ Catheter, CARTO™ VIZIGO™ Bi-Directional Guiding Sheath, PENTARAY™ NAV ECO High Density Mapping Catheter, OCTARAY™ Mapping Catheter with TRUEref™ Technology, OPTRELL™ Mapping Catheter with TRUEref™ Technology, DECANAV™ Mapping Catheters, and Webster™ CS Catheter.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions. Caution: US law restricts this device to sale by or on the order of a physician.
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