AVEIRTM Leadless Pacemakers

Atrial and Ventricular Single Chamber Leadless Pacemakers (LP)

Purple background image with a blue illustrated heart

Tailored Leadless Pacing. Implant an atrial or ventricular device alone. Or both combined.1

AVEIR AR Atrial LP. AVEIR VR Ventricular LP. Individually, they are capable of AAI(R) or VVI(R). But together they can provide the world's first leadless DDD(R) system. Tailor therapy by implanting one or both devices based on your patient’s indications and needs.

Learn more about the benefits of this system that is redefining the landscape of cardiac pacing below. 

AVEIR™ AR ATRIAL LP

  • Sinus node dysfunction, normal AV and intraventricular conduction systems

AVEIR™ VR VENTRICULAR LP

  • Significant bradycardia and normal sinus rhythm with only rare episodes of AV block or sinus arrest
  • Chronic atrial fibrillation
AVEIR™ DR DUAL CHAMBER LEADLESS PACEMAKER SYSTEM in heart

AVEIR™ DR DUAL CHAMBER LP SYSTEM

  • Sick sinus syndrome
  • Chronic, symptomatic 2nd-and 3rd-degree AV block
  • Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out

Provide AAI(R) pacing with the the only atrial leadless pacemaker.2

 

Leadless pacing has been limited to the right ventricle, necessitating the use of conventional pacemakers. Now, patients can experience the power of atrial only leadless pacing with an AVEIR AR LP. AVEIR AR LP offers a safe3, effective3, and upgradeable1 pacing solution for patients with sinus node dysfunction and normal AV and intraventricular
conduction systems.

 

AVEIR AR LP Clinical Outcomes3

Above 95.2% Effective 

88%

Above 90.3% Safe

92.5%

ELECTRICAL PERFORMANCE SUCCESS RATE3 in early clinical evidence patients with acceptable atrial device capture threshold and sensing amplitude.*

FREEDOM FROM COMPLICATIONS.3 The inclusion of arrhythmias as a safety end point increased the overall incidence of complications as compared with other studies of leadless pacemakers, which excluded arrhythmias from the end point.

*Atrial device capture threshold of ≤3.0V@04ms and ≥0.5mV at 3 month visit.

Upgradeable System1

Patient therapy can be tailored by implanting an atrial or ventricular device alone, or both combined for dual chamber support. The option to upgrade over time allows you to meet your patient’s needs today and adapt to common disease progression later.


Treatment option 1: Start with the atrial device. 

Treat sinus node dysfunction today.

AVEIR AR in heart

Add a ventricular device for heart block later.

AVEIR DR in heart

i2i™ communication is enabled.

i2i symbol

Activate dual chamber pacing therapy DDD(R) via i2i communication.

AVEIR DR in heart

Treatment option 2: Start with the ventricular device. 

Treat rare intermittent heart block today.

AVEIR VR in heart

Add an atrial device for sick sinus syndrome later.

AVEIR DR in heart

i2i communication is enabled.

i2i symbol

Activate dual chamber pacing therapy DDD(R) via i2i communication.

AVEIR DR in heart

Indications for Ventricular Single Chamber Leadless Pacing

Ventricular Pacing for Patients with:

▪ Significant bradycardia and normal sinus rhythm with only
   rare episodes of AV block or sinus arrest

▪ Chronic atrial fibrillation

Aveir atrial pacing pacemaker

Designed for Long-Term Retrieval

The AVEIR VR LP's predicate device has an overall long-term retrieval success rate above 88% with helix fixation through 9 years of retrieval experience.5  Limited data is available for AVEIR VR LP.

The AVEIR VR LP's predicate device has an overall long-term retrieval success rate of 92.5% for implants ≥ 5 years.5

88%
92.5%

Long Lasting

Increased projected battery longevity over current available leadless pacemakers4,6* opens the door to more patients.

Mean ± SD: 17.6±6.6 years7
95% CI: 16.6 to 18.6 years

Projected years of battery life comparison Aveir VR leadless pacemaker vs Micra leadless pacemaker

The average battery longevity among Leadless II phase 2 IDE patients at 1 year follow-up is estimated to be 17.6 years7

48% of the study patients have an estimated battery longevity of over 20 years.7

Up to
Twice the Battery Capacity
of current VR leadless pacemakers4,6*

Aveir VR Leadless Pacemaker battery capacity 243 mAh Micra Leadless Pacemaker  120 mAh

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REFERENCES

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

**For additional information about specific MR Conditional, including warnings, precautions, adverse conditions to MRI scanning and potential adverse events, please refer to the MRI-Ready Leadless Systems Manual at medical.abbott/manuals or check our MRI-Ready resources at cardiovascular.abbott/mriready
 

  1. AVEIR Leadless Pacemakers and Delivery Catheter IFU. ARTEN600284235.
  2. AVEIR DR FDA Approval
  3. Knops, Reinoud E., et al. “A Dual- Chamber Leadless Pacemaker.” New England Journal of Medicine (2023). DOI: 10.1056/ NEJMoa2300080.
  4. AVEIR™ VR Leadless Pacemaker and Delivery Catheter IFU. ARTEN600175956.
  5. Reddy, VY, et al. Worldwide Experience with Leadless Pacemaker Retrievals at 9 years. Presented at 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific Session; Nov 18-20, 2022; Singapore.
  6. Micra VR IFU M991010A001 REV. B
  7. Reddy VY, Exner D, et al. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial. JACC : Clinical Electrophysiology 2023, DOI: 10.1016/j.jacep.2023.01.031


ADDITIONAL REFERENCES

  1. Sattar et al. Complications of leadless vs conventional (lead) artificial pacemakers - a retrospective review. Journal of community hospital internal medicine perspectives vol. 10,4 328-333. 2 Aug. 2020, doi:10.1080/20009666.2020.178690
  2. Reddy VY, Cantillon DJ, John IP. San Francisco, CA: 6 May 2016. A comparative study of acute and mid-term complications of leadless vs transvenous pacemakers. Late-Breaking Clinical Trials II. Presented at Heart Rhythm Society 2016; pp. 02–04. Abstract LBCT.
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Reimbursement & Coding

MAT-2115643 v10.0 | Item is approved for U.S. use only