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Safe and effective long-term retrieval of AVEIR™ DR Dual Chamber Leadless Pacemaker (LP) System demonstrated in a preclinical study

Abbott Cardiac Rhythm Management | February 8, 2024
 
Aveir DR Leadless Pacemaker

With the introduction of the world’s first dual chamber LP system1, leadless technology is on the verge to become the preferred alternative to traditional transvenous pacemakers. This increase in utilization is what will make retrieval one of the most important capabilities to consider when accommodating future upgrades or replacements.

The AVEIR DR LP System has a custom-designed retrieval catheter supported by a step-by-step retrieval protocol.2 All AVEIR™ devices have an active fixation design that uses a screw-in mechanism to enable both implantation and long-term retrieval of the atrial and ventricular devices.3 With the launch of this new product, a study was implemented to evaluate the performance and safety of retrieving chronically implanted dual chamber LPs in a preclinical setting.

Using nine healthy ovine subjects, atrial and ventricular LPs were implanted in the right atrial appendage and right ventricular apex for this study. The LPs were retrieved around two years later using the custom-designed retrieval catheter by snaring, docking, and unscrewing from the myocardium. Comprehensive necropsy/histopathology studies were then conducted to evaluate the outcomes.

At a median of 1.9 years postimplant (range, 1.8–2.6), 100% of the LPs (9 atrial, 9 ventricular) were retrieved from all 9 ovine subjects without complications.4

The median retrieval duration for both LPs from the “first catheter in” to the “last catheter out” was 13.3 minutes (range, 2.5–36.4).4

Results also showed4:

  • Minimal tissue disruption
  • Intact fibrous tissue limited to the distal device body
  • No significant device-related trauma
  • No perforation
  • No pericardial effusion
  • No right-heart or tricuspid valve injury
  • No chronic pulmonary thromboembolism observed at necropsy

Learn more about this exciting preclinical study that demonstrates the safe and effective retrieval of chronically implanted, helix-fixated, dual chamber LP systems and how it paves the way for more clinical studies of LP retrieval here.

Visit our website to discover what this groundbreaking technology can do for your practice.

 

REFERENCES

  1. AVEIR™ DR FDA Approval.
  2. AVEIR™ Retrieval Catheter IFU. ARTMT600174816.
  3. AVEIR™ Leadless Pacemakers and Delivery Catheter IFU, ARTEN600284235.
  4. Banker RS, Rippy M, Cooper N, et al. Retrieval of chronically implanted dual-chamber leadless pacemakers in an ovine model. Circulation: Arrhythmia and Electrophysiology. 2023;16. https://doi/10.1161/CIRCEP.123.012232

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