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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

PROVEN SAFETY IN REAL-WORLD POPULATIONS

DATA FROM ASIA PACIFIC HEART RHYTHM SOCIETY (APHRS) 2025

AVEIR™ DR PROVIDES SIGNIFICANT ADVANTAGES OVER TRANSVENOUS PACEMAKERS (TVPs)4


REAL-WORLD RESULTS FROM COMPARING 759 AVEIR™ DR PATIENTS WITH 77,422 TV PATIENTS

LOWER COMPLICATIONS

  • 41% lower rate of overall complications compared to TVPs at 6 months (4.1% vs 6.9%, P<0.01)
  • 52% lower rate of device-related complications for AVEIR™ DR compared to TVPs at 6 months (2.8% vs 5.9%, P<0.01

LOWER DEVICE REINTERVENTIONS

  • 51% lower rate of overall device reinterventions for AVEIR™ DR compared to TVPs at 6 months (2.1% vs 4.3%, P<0.01)

COMPARABLE MORTALITY

  • Comparable all-cause mortality over 30 days and 6 months in the AVEIR™ DR group
Safety and efficacy

AVEIR™ DR LP SYSTEM IMPLANT-TO-IMPLANT (i2i™) STUDY MET 3-MONTH SAFETY AND EFFICACY ENDPOINTS AS HIGHLIGHTED IN THE NEW ENGLAND JOURNAL OF MEDICINE5

Patients with successful dualchamber procedures

Patients achieved atrioventricular synchrony (AVS) performance endpoint

Patients free from system-related complications*

Patients with acceptable atrial device pacing capture threshold and sensing amplitude

*Serious device and procedure related adverse events.

FEW COMPLICATIONS OCCURRED BETWEEN 3 AND 6 MONTH FOLLOW-UP6

3 serious adverse device effects occurred between 90 and 180 days

  • Threshold elevation
  • Pre-syncope
  • False magnet mode

Patients free from system-related complications at 3 months*

Patients free from system-related complications at 6 months*

The incidence of acute complications was similar to that observed in studies of transvenous dual-chamber pacemakers.7,8,9

*Kaplan-Meier analysis was used to calculate ‘complication-free’ rate across 6 months.

Device longevity

SIGNIFICANT BATTERY LONGEVITY INCREASE OBSERVED IN AAI(R)+VVI† PACING MODE10

  • Existing or de novo implanted AVEIR™ DR leadless pacemaker (LP) systems were evaluated at 6 centers (N=139)
  • At enrollment, battery longevity projections were recorded for both atrial and ventricular LPs when programmed to dual-chamber pacing rate response [DDD(R)] mode. All LP systems were then programmed to atrial pacing rate response + single chamber ventricular [AAI(R)+VVI†] mode
  • At 6 months, intra-patient total projected longevities were compared for DDD(R) at enrollment vs AAI(R)+VVI† at 6 months
  • In order to ensure accurate initial DDD(R) longevity estimates (e.g., pacing burden and i2i™ transmission counts), only patients enrolled with existing implants already programmed to DDD(R) were used for the battery longevity comparisons. Of these, 32 attended the 6-month visit

LONGEVITY IMPROVEMENT

Battery longevity comparison of DDD(R) at enrollment versus AAI(R)+VVI† at 6 months. Longevities were limited to patients with existing implants in DDD(R) mode who completed the 6-month visit (n=32).*

*Error bars show mean ± standard deviation. ‡ indicates statistical differences between DDD(R) and AAI(R)+VVI.†

†AAI(R)+VVI pacing mode should not be used in patients without intact AV node conduction, or with chronic atrial fibrillation or atrial flutter.
ALP, atrial leadless pacemaker; i2i, implant-to-implant; VLP, ventricular leadless pacemaker

Aveir™ DR LP 2-year summary

AVEIR™ DR LP DEMONSTRATES 2-YEAR SAFETY, ELECTRICAL PERFORMANCE AND HIGH i2i COMMUNICATION11
 

KAPLAN MEIER ANAYLSIS OF COMPLICATION FREE RATE THROUGH 24 MONTHS

  • 100% IMPLANT SUCCESS
  • HIGH LONG-TERM SAFETY: 
    97.0% complication-free survival at implant, 92.9% at 1 year, 91.3% at 2 years (most events in first 90 days)
  • STABLE ELECTRICAL PERFORMANCE: 
    decreasing capture thresholds, increasing atrial sensing, stable impedance
  • RELIABLE i2i COMMUNICATION: 
    90% success maintained through 24 months

CI, confidence interval; i2i, implant-to-implant.

0-90 day complications (number of patients)91-365 day complications (number of patients)366-720 day complications (number of patients)
Cardiac arrhythmia - Atrial fibrillation (3)Thereshold elevation (1)Thrombosis (1)
Thereshold elevation (1)Oversensing (1) 
Device dislodgement (1)  
Connext
TV

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THERAPY

Find out more

TV

Understanding AVEIR VR Retrieval

AVEIR VR Simulated Retrieval: A Step-by-Step Demonstration

Why Leadless Pacing Summit 2026 Matters

Why the Leadless Pacing Summit 2026 is Important for Physicians and Patients

AVEIR Atrial LP AAI Implant Training Supplement

AVEIR Atrial LP AAI Implant Med-in-a-Box: Step-by-Step Training Guide

AVEIR DR Virtual Implant Training Supplement

AVEIR DR Leadless Pacemaker Virtual Implant: Step-by-Step Guide

Leadless in Congenital Patients

Leadless Pacing in Congenital Heart Patients with Prof. Wong

When Patients Evolve: Upgradability in Leadless

Leadless Upgradability and Evolving Patient Needs with Prof. Tajstra

Optimizing Tricuspid Valve Crossing: Case example

Optimizing Tricuspid Valve Crossing Case 2 with Dr. Jacon

Optimizing Tricuspid Valve Crossing: Case example

Optimizing Tricuspid Valve Crossing Case with Prof. Curcio

Health Economics of Leadless Therapy

Health Economics of Leadless Therapy with Prof. Vinolas Prat

Learn AVEIR Leadless Pacemaker Follow-Up Checks

Learn How to Perform Follow-Up Checks on the AVEIR Leadless Pacemaker

References
  1. AVEIR™ Leadless Pacemakers and Delivery Catheter IFU. ARTEN600361108.
  2. Micra‡ VR2 MC2VR01 IFU.
  3. Micra‡ AV2 MC2AVR1 IFU.
  4. Lo M, Amin A, Kowalski M, et al. Are Dual Leadless Pacemakers Safer than Transvenous Devices? Real-World Evidence from AVEIR™ DR Coverage with Evidence Development Study. Abstract presented at: Asia Pacific Heart Rhythm Society; Nov 12-15, 2025; Yokohama, Japan. [Data obtained from final presentation].
  5. 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. 
  6. Knops RE, Reddy VY, Ip JE, et al. Safety and Electrical performance of the first dual-chamber leadless pacemaker at 6 months post-implant. Presented at: Asia Pacific Heart Rhythm Society; Sep 1-3, 2023; Hong Kong. 
  7. Udo EO, Zuithoff NP, van Hemel NM, et al. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012;9(5):728-35. doi: 10.1016/j.hrthm.2011.12.014. 
  8. 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.
  9. Gimbel JR, Bello D, Schmitt M, et al. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. 2013;10(5):685-91. doi: 10.1016/j. hrthm.2013.01.022. 
  10. Ip JE, Badie N, Rashtian M, et al. Novel Pacing Mode Conserves Battery in Dual-Chamber Leadless Pacemakers. J Cardiovasc Electrophysiol. 2026;37(2):338-346. doi: 10.1111/jce.70224.
  11. Garweg C, Defaye P, Neuzil P, et al. Long term outcomes of dual chamber leadless pacemaker insights from European patients data. Poster presented at: European Heart Rhythm Association; April 12-14, 2026; Paris.
  12. Nilsson KR Jr, Birgersdotter-Green U, Saleem-Talib S, et al. Leadless atrial versus transvenous pacing for sinus node dysfunction: 1-year outcomes from the leadless ARRIVE real-world study. Europace. 2026;28(4):euag072. doi: 10.1093/europace/euag072.
  13. 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.
  14. Nilsson KR, Birgersdotter-Green UM, Diaz JO, et al. PO-06-004 Leadless vs. transvenous atrial pacemakers: Real-world evidence from AVEIR™ AR coverage with evidence development study. Heart Rhythm. 2025;22(4):S633. Doi:10.1016/j.hrthm.2025.03.1552.
  15. I p JE, Brady PA, Kroman AM, et al. Leadless Versus Transvenous Single-Chamber Ventricular Pacemakers: Real-World Evidence From AVEIR™ VR Coverage With Evidence Development Study. J Am Heart Assoc. 2025;14(21):e042471. doi: 10.1161/JAHA.125.042471. 
  16. 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.
  17. Reddy VY, et al. Chronic Performance of a Novel Leadless Pacemaker: 1 Year Results from the LEADLESS II Trial. Presented at: Asia Pacific Heart Rhythm Society; Nov 18-20, 2022; Singapore.

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