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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 WORLD’S FIRST DUAL-CHAMBER LEADLESS PACEMAKER (LP) SYSTEM


*Ventricular device providing AV synchrony based on the mechanical sensing of atrial activity. Device provides AV synchrony at rest and rate responsive (VVIR) pacing during periods of high patient activity.
† AAI(R)+VVI mode should not be used in patients without intact AV node conduction, or with chronic atrial fibrillation or atrial flutter.
AAI, atrial pacing; AAI(R), atrial pacing rate response; AF, atrial fibrillation; AV, atrioventricular; AVB, atrioventricular block; AVM, atrial management; DDD, dual-chamber pacing; DDD(R), dual-chamber pacing rate response; DR, double chamber; ESC, European Society of Cardiology; i2i, implant-to-implant; LP, leadless pacemaker; SND, sinus node dysfunction; TV, transvenous; VVI, single chamber ventricular pacing; VVIR, single chamber ventricular pacing rate response.

READ 2021 ESC GUIDELINES

Beat-to-beat synchrony

AVEIR™ DR leadless pacemaker system is capable of pacing and sensing in both chambers through the combination of an atrial leadless pacemaker (AVEIR™ AR2 LP) and a ventricular leadless pacemaker (AVEIR™ VR LP).6,7

Dual-chamber, leadless synchronous pacing between the atrium and the ventricle is made possible with industry-first, proprietary implant-to-implant (i2i™) communication technology capable of providing true DDD(R) pacing for continuous, atrioventricular synchrony (AVS), regardless of patient posture.6,7

Mean AVS observed for multiple postures and gaits (including sitting, supine, left lateral recumbent, right lateral recumbent, standing, normal walking and fast walking).7

i2i TECHNOLOGY

CONTINUOUS AVS VIA i2i™ TECHNOLOGY6

  • Implants communicate beat-to-beat
  • Transmissions are low energy, sub-threshold pulses using the body’s conductive nature
  • Data pulses are delivered concurrently with each paced or sensed event, without impact on pacing or sensing

Patients achieved AVS performance endpoint7

Implant-to-Implant (i2i™) Technology6

This novel technology features paired, co-implanted devices employing low-energy, subthreshold pulses between them using the conductive nature of the body’s blood pool and myocardial tissue.

High-frequency pulses are delivered concurrently with each locally paced or sensed event without impact on pacing or intrinsic sensing.

Workflow

THE AVEIR™ DR DUAL-CHAMBER LP SYSTEM IMPLANT PROCEDURE.6

PREP the patient’s skin and apply electrocardiogram electrodes. CONNECT to the Merlin™ Patient Care System (PCS) Programmer via AVEIR™ Link Module

After gaining femoral vein access and visualizing the heart’s anatomy and size via imaging, INSERT delivery catheter with attached ventricular LP. Navigate to right ventricle and map for ideal implant site.

FIXATE ventricular LP, go into tether mode to assess electrical measurements, release, and then withdraw the delivery catheter

Load the atrial LP onto a new delivery catheter, INSERT and navigate to right atrium and map for ideal implant site

FIXATE atrial LP, go into tether mode to assess electrical measurements, finalize atrial device

PAIR devices via implant-to-implant ( i2i™) technology, assess i2i communication between the two LPs, and program dual-chamber or an appropriate mode

RELEASE atrial device, remove delivery catheter and close access

WATCH THE AVEIR™ DR LP IMPLANTATION PROCEDURE

Procedural efficiency

AVEIR™ DR (DUAL CHAMBER)8

  • Total procedure time: sheath insertion–removal: 90 ± 37 min
  • Dual-chamber procedure: 74 ± 32 min
  • Fluoroscopy time: 20 ± 13 min

Learning curve after ≥9 procedures:

  • Time reduced by 19–36%
  • Complication-free rate improved from 89% to 98%
  • Implant success: 98.7%
Device longevity

DUAL-CHAMBER LONGEVITIES WITH AVEIR™ AR2 ATRIAL LP1,6

AVEIR™ AR2 ATRIAL DEVICE

Parameters: DDD(R), 50 bpm, 300 Ω, i2i™ = 4/4, model LSP203A

LONGEVITY* (YEARS)
Pulse width

%
PACING
PACE
AMPLITUDE
0.25 ms0.4 ms0.8 ms
0%2.5 V10.310.310.3
50%1.5 V9.18.67.7
2.5 V7.66.75.4
100%1.5 V8.17.36.1
2.5 V6.05.03.7


Mean atrial device impedance at 12-month IDE follow-up9

AVEIR™ VR VENTRICULAR DEVICE

Parameters: DDD(R), 50 bpm, 500 Ω, i2i™ = 4/4, models LSP112V/LSP202V

LONGEVITY* (YEARS)
Pulse width

%
PACING
PACE
AMPLITUDE
0.25 ms0.4 ms0.8 ms
0%2.5 V14.014.014.0
50%1.5 V12.712.111.0
2.5 V11.19.98.1
100%1.5 V11.710.79.0
2.5 V9.27.75.6


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.
DDD(R), dual-chamber pacing rate response; IDE, investigational device exemption; i2i, implant-to-implant.

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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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