Accessories

Support tools engineered to optimize procedural performance in cardiac rhythm management

Healthcare Professionals Cardiac Rhythm Management Cardiac Rhythm Management Products Accessories

FLEXIGO 3D 

LEFT BUNDLE BRANCH AREA PACING (LBBAP) LEAD DELIVERY SYSTEM

A new range for LBBAP implantation:
  • Targeted LBBAP Positionning: 2 dedicated curvatures for precise positioning. Designed using advances 3D modelling of real life anatomy1
  • Simple navigation: Effortless navigation with a supportive, flexible catheter for precise lead placement2-4
  • Supportive: Reinforced thermoplastic braiding for superior kink resistance 5

 

Versatile, the FLEXIGO™ 3D is available in 8 options:

  • 3 shapes for every patients’ needs: further to the Shape 20 designed for normal size hearts, Flexigo also offers Shape 10 designed for smaller hearts and Shape 30 for large and dilated hearts.
  • 2 diameters to suit every lead choice (4.1 F up to 6F)
  • 3 lengths : 40, 41 and 45cm.

 

The FLEXIGO 3D delivery catheter and slitter demonstrated good overall safety performance, with no abnormal safety trends observed, and exhibited acceptable implant performance for brady pacing.* 

92.0% of patients with ventricular pacing lead successfully implanted at the interventricular septum and meeting LBBAP criteria with use of the FLEXIGO 3D delivery catheter.* 

Vast majority of operators were satisfied with procedural performance of catheter and slitter.*

 
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  1. 99% of physicians were satisfied of the catheter preformed shape and adequacy during clinical evaluation (Polaris study*)
  2. 100% investigator satisfaction rate on catheter X-ray visibility during clinical evaluation (POLARIS study*)
  3. 99% of investigators satisfaction rate on the lead insertion and advancement in the catheter during clinical evaluation (POLARIS study*).
  4. 99% of investigators satisfaction rate on the torque response during clinical evaluation (POLARIS study*)
  5. 100% of physicians were satisfied of the catheter kink resistance during clinical evaluation (Polaris study*)

* POLARIS study (EU Identification Number: CIV-FR-25-01-050957): CLINICAL INVESTIGATION REPORT PRIMARY ENDPOINT RESULTS PHASE I – internal file. For more information about the clinical trial, please look at https://clinicaltrials.gov/study/NCT06453850?term=polaris%20septum&rank=1