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SETTING THE PACE WITH
AVEIR™ LEADLESS
PACEMAKERS


The only leadless solutions that can provide therapy
for all common pacemaker indications1,2,3

THE VENTRICULAR LEADLESS PACEMAKER (LP)

SINGLE HELIX DESIGN FOR VENTRICULAR THERAPY1,6

  • 1.63 mm inactive outer helix provides primary fixation
  • Electrical mapping prior to fixation
  • Recommended implant site: low to mid septal area of the right ventricle

ELECTRICAL PERFORMANCE FROM THE LEADLESS II PHASE 2 STUDY*

Patients with acceptable ventricular device pacing capture threshold and sensing amplitude.14

*Electrical performance data based on predecessor model LSP112V.

At just 38.0mm, the AVEIR™ VR FPO Ventricular Leadless Pacemaker (LP) has three time less volume than a standard AAA battery1,6

Workflow

AVEIR™ VR VENTRICULAR LP IS IMPLANTED IN THE HEART THROUGH A MINIMALLY INVASIVE CATHETER PROCEDURE6

CONNECT patient’s skin electrodes to Merlin™ Patient Care System (PCS) Programmer via AVEIR™ Link Module

INSERT the LP via ergonomic catheter for minimally invasive procedure ensuring helix is fully covered during catheter navigation

MAP atrial implanting location before fixation by touching endocardium with LP’s tip electrode

FIXATE the LP to the atrial endocardium
using the screw-in mechanism

RELEASE the LP and withdraw
delivery catheter

Procedural efficiency

AVEIR™ VR LP14

  • Total procedure time: 39.9 ± 21.6 min
  • Fluoroscopy time: 9.4 ± 8.5 min
  • Repositioning: Avoided in 83% of cases (due to pre-fixation mapping)

PROCEDURE DURATION

VLP, ventricular leadless pacemaker.

Electrical mapping prior to fixation6

Patients with successful ventricular implants (≤1 repositioning attempts)7

Retrieval success rates

RETRIEVAL CATHETER

RETRIEVAL SUCCESS RATES REMAINED HIGH, REGARDLESS OF IMPLANT DURATION15,16*

OVERALL LONG-TERM RETRIEVAL SUCCESS RATE

The AVEIR™ VR Ventricular LP predecessor has a longterm retrieval success rate of 88% with helix fixation through 9 years regardless of implant duration.

* Limited data is available for AVEIR™ LPs.

RETRIEVAL SUCCESS RATES BY DURATION

Device longevity

INDEPENDENT ATRIAL PACING MODE LONGEVITIES1

AVEIR™ VR VENTRICULAR DEVICE

Parameters: VVI(R), 50 bpm, 500 Ω, models LSP112V/LSP202V

LONGEVITY* (YEARS)
Pulse width

%
PACING
PACE
AMPLITUDE
0.25 ms0.4 ms0.8 ms
0%2.5 V27.227.227.2
50%1.5 V22.921.117.9
2.5 V18.115.211.3
100%1.5 V19.817.213.3
2.5 V13.510.57.0

Mean ventricular device impedance
at 12-month IDE follow-up10

*Longevity estimations may vary among different software and firmware versions based on approval timings within the various regulatory agencies.
IDE, investigational device exemption; VR, ventricular device; VVI(R), single chamber ventricular response rate.

LONG LASTING

Increased projected battery longevity over currently available leadless pacemakers opens the door to more patients.2,17

Mean ± SD: 17.6 ± 6.6 years18  |  95% Cl: 16.6 to 18.6 years18

BATTERY CAPACITY

At least
1.7x the battery capacity 
of current ventricular LPs17,18*

  • The average battery longevity among Leadless II phase 2 IDE patients at 1-year follow-up is estimated to be 17.6 years18
  • 48% of the study patients have an estimated battery longevity of over 20 years18

*Battery longevity estimates based on projections derived from published technical specifications and the ISO standard settings.

AVEIR™ LEADLESS PACEMAKER FOLLOW-UP PROCEDURE

Hear from a cardiac electrophysiologist about the AVEIR™ LP follow-up procedure.

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References
  1. AVEIR™ Leadless Pacemakers and Delivery Catheter IFU. ARTEN600361108. 
  2. Micra‡ VR2 MC2VR01 IFU. 
  3. Micra‡ AV2 MC2AVR1 IFU. 
  4. Glikson M, Nielsen JC, Kronborg MB, et al. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. Erratum in: Eur Heart J. 2022 May 1;43(17):1651. doi: 10.1093/eurheartj/ehac075.
  5. Kusumoto FM, Schoenfeld MH, Barrett C, et al. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. J Am Coll Cardiol. 2019;74(7):932-987. doi: 10.1016/j.jacc.2018.10.043. Erratum in: J Am Coll Cardiol. 2019;74(7):1014-1016. doi: 10.1016/j.jacc.2019.06.046. 
  6. AVEIR Leadless Pacemakers and Delivery Catheter IFU. ARTEN600175957; ARTEN600307044; ARTEN600361109. 
  7. Knops RE, Reddy VY, Ip JE, et al. A Dual-Chamber Leadless Pacemaker. N Engl J Med. 2023;388(25):2360-2370. doi: 10.1056/NEJMoa2300080.
  8. Doshi RN, Ip JE, Defaye P, et al. Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study. Heart Rhythm. 2025;22(9):2391-2400. doi: 10.1016/j.hrthm.2025.03.1941. 
  9. Knops RE, Ip JE, Doshi R, et al. One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker. Circ Arrhythm Electrophysiol. 2025;18(4):e013619. doi: 10.1161/CIRCEP.124.013619. 
  10. Knops RE, Ip JE, Doshi R, et al. One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker. (Supplementary Appendix). Circ Arrhythm Electrophysiol. 2025;18(4):e013619. doi: 10.1161/CIRCEP.124.013619.
  11. Cantillon D, et al. Percutaneous implantation of a dual-chamber leadless cardiac pacemaker system with bidirectional communication for atrioventricular synchrony. Presented at: Heart Rhythm Society; May 19-21, 2023; New Orleans, USA.
  12. Nair DG, Lee KW, Badie N, et al. Atrial helix-fixation leadless pacemaker: real-world single-chamber implant experience. J Interv Card Electrophysiol. 2025;68(6):1319-1325. doi: 10.1007/s10840-025-02041-8. 
  13. Ip J, Doshi R, et al. Chronic Retrieval Outcomes for an Atrial Leadless Pacemaker. Presented at: Heart Rhythm Society; Apr 25-27, 2025; San Diego, USA. 
  14. Reddy VY, Exner DV, Doshi R, et al. Primary Results on Safety and Efficacy From the LEADLESS II-Phase 2 Worldwide Clinical Trial. JACC Clin Electrophysiol. 2022;8(1):115-117. doi: 10.1016/j.jacep.2021.11.002.
  15. Reddy, VY, et al. Worldwide Experience with Leadless Pacemaker Retrievals: A Worldwide Nanostim Experience out of 9y. Presented at: Asia Pacific Heart Rhythm Society; Nov 18-20, 2022; Singapore. 
  16. Neuzil P, Exner DV, Knops RE, et al. Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers. J Am Coll Cardiol. 2025;85(11):1111-1120. doi: 10.1016/j.jacc.2024.10.094. 
  17. AVEIR™ VR Leadless Pacemaker and Delivery Catheter IFU. ARTEN600384624.
  18. Reddy VY, Exner DV, Doshi R, et al. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial. JACC Clin Electrophysiol. 2023;9(7 Pt 2):1187-1189. doi: 10.1016/j.jacep.2023.01.031.

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‡ Indicates a third-party trademark, which is property of its respective owner.

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