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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

AVEIR™ VR – SIGNIFICANT ADVANTAGES OVER TRANSVENOUS PACEMAKERS (TVPs)15

REAL-WORLD RESULTS FROM COMPARING 2,425 AVEIR™ VR PATIENTS WITH 21,335 TV PATIENTS

LOWER COMPLICATIONS

  • 30% lower overall 12-month complication rate compared with TVPs (4.1% vs 5.7%, P=0.02)
  • 47% lower device-related complication rate (2.8% versus 5.2%, P=0.0002)
  • Comparable cardiac effusion/perforation rates (0.4% and 0.3%, P=0.45)

LOWER DEVICE REINTERVENTIONS

  • AVEIR™ VR had 61% lower rate of device reinterventions compared with TV-single chamber ventricular (VVI) (1.2% vs 3.2%; HR, 0.39, P<0.0001)

COMPARABLE MORTALITY

  • Adjusted 12-month mortality for AVEIR™ VR was significantly lower compared to TVPs (17.0% vs 18.2%; HR 0.93, P=0.02)
Leadless II phase 2 investigational device exemption (IDE) study

DATA CONFIRMS AVEIR™ LPs SAFETY AND EFFICACY16

Implant success

Patients achieved primary safety endpoint

Acceptable pacing capture threshold and sensing amplitude

Cases required NO repositioning during implant

Zero dislodgements

Observed success rate based on pacing threholds only

DEVICE ELECTRICAL MEASUREMENTS AT 12 MONTHS17

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TV

CONNECT TO THE LATEST
IN STRUCTURAL HEART
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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