AVEIR™ DR Dual Chamber Leadless Pacemaker System

Setting the Pace With Dual Chamber Leadless Pacing

Beat-to-Beat Synchrony | Upgradeable System | Long‑Term Retrieval

Now FDA Approved

Introducing the World’s First Dual Chamber Leadless Pacemaker System1

Two distinct devices. Each specifically designed for the right atrium or right ventricle.2

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New Leadless Pacing Options2

With sensing and pacing in both the right atrium and right ventricle, you now have new AAI, VVI, and DDD leadless configurations to consider. You can match your patient's pacing needs today and then upgrade over time as those needs change.

Illustration of proprietery implant-to-implant (i2i) communication
Illustration of proprietery implant-to-implant (i2i) communication

Continuous AV, Beat-to-Beat Synchrony via Implant-to-Implant (i2i) Technology2

To support the dual chamber therapy, each implant communicates beat-to-beat with a paired, co-implanted device using implant-to-implant (i2i) communication. This novel technology employs low energy, subthreshold pulses between implanted devices using the conductive nature of the body's blood pool and myocardial tissue. These high frequency pulses of data are delivered concurrently with each locally paced or sensed event, without impact on pacing or intrinsic sensing.

Upgradeable System2

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.

Aveir DR Workflow 1

Option to Start With Ventricular Pacing
Treat patients for rare intermittent A-V block today.

Aveir DR Workflow 2
Aveir DR Workflow 3

Add Atrial Pacing Later
Treat those same patients by adding an atrial device if sick sinus syndrome develops later to provide DDDR therapy.

Aveir DR Workflow 4
Aveir DR Workflow 5

Achieve Dual Chamber Pacing
Now you have options to adapt to patient needs over time.

Long-Term Retrieval2

Long-term retrieval allows for the replacement of the atrial or ventricular device at end of service without leaving hardware behind.

Aveir DR Long Term Catheter

Specialty designed retrieval catheter supported by step-by-step protocol.

Through nine years regardless of implant duration, AVEIR VR™ predicate device has a long-term retrieval success rate3

Aveir DR has an 88% long-term retrieval success rate
Aveir DR's active fixation helix

Active fixation helix uses a screw-in mechanism to enable both implantation and long-term retrieval of the leadless pacemaker.

Proven Clinical Evidence4

See evidence of proven safety and efficacy at 3-month follow-up from AVEIR DR i2i IDE study in the New England Journal of Medicine.

Mean AV synchrony observed for multiple postures and gaits (including sitting, supine, left lateral recumbent, right lateral recumbent, standing, normal walking and fast walking)4


Across 300 patients, the procedure was successful in 295 patients for a rate of


Powering Hearts Beat to Beat

Abbott Cardiac Rhythm Management is partnering with you to personalize care from diagnosis through treatment and ongoing management.

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Learn More About AVEIR VR

* Mean AV synchrony observed for all 7 different postures (including sitting, supine, left lateral recumbent, right lateral recumbent, standing, normal walking and fast walking) ranging from 95.3% to 99.2%


  1. AVEIR DR FDA approval
  2. AVEIR Leadless Pacemakers and Delivery Catheter IFU. ARTEN600284235.
  3. Reddy, VY, et al. Worldwide Experience with Leadless Pacemaker Retrievals: A Worldwide Nanostim Experience out of 9y. Presented at: APHRS 2022; Nov 18-20, 2022; Singapore.
  4. The New England Journal of Medicine (NEJM), May 2023, www.nejm.org/doi/full/10.1056/NEJMoa2300080

AVEIR™ DR Important Safety Information

Rx only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications,  contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The AVEIR™ Leadless Pacemaker system is indicated for management of one or more of the following permanent conditions: Syncope, Pre-syncope, Fatigue, Disorientation. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing is indicated for patients exhibiting: Sick sinus syndrome, Chronic, symptomatic second- and third-degree AV block , Recurrent Adams-Stokes syndrome, Symptomatic bilateral bundle-branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with: Sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular pacing is indicated for patients with: Significant bradycardia and normal sinus rhythm with only rare episodes of AV block or sinus arrest, Chronic atrial fibrillation, Severe physical disability. MR Conditional: The AVEIR Leadless Pacemaker is conditionally safe for use in the MRI environment and according to the instructions in the MRI-Ready Leadless System Manual.

Intended Use: The AVEIR™ Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle and/or right atrium. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy within the implanted chamber for the target treatment group. The LP is also intended to operate optionally with another co-implanted LP to provide dual-chamber pacing therapy.

The AVEIR™ Delivery Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.

Contraindications: Use of the AVEIR™ Leadless Pacemaker is contraindicated in these cases:

  • Use of any pacemaker is contraindicated in patients with a co-implanted ICD because high-voltage shocks could damage the pacemaker and the pacemaker could reduce shock effectiveness.
  • Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.
  • Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor driven rates.
  • Use is contraindicated in patients with an implanted vena cava filter or mechanical tricuspid valve because of interference between these devices and the delivery system during implantation.
  • Persons with known history of allergies to any of the components of this device may suffer an allergic reaction to this device. Prior to use on the patient, the patient should be counseled on the materials (listed in the Product Materials section of the IFU) contained in the device and a thorough history of allergies must be discussed.

Adverse Events: Potential complications associated with the use of the AVEIR™ Leadless Pacemaker system are the same as with the use of single or dual chamber pacemakers with active fixation pacing leads including, but not limited to: Cardiac perforation, Cardiac tamponade, Pericardial effusion, Pericarditis, Valve damage and/or regurgitation, Heart failure, Pneumothorax/hemothorax, Cardiac arrhythmias, Diaphragmatic/phrenic nerve stimulation / extra-cardiac stimulation, Palpitations, Hypotension, Syncope, Cerebrovascular accident, Infection, Hypersensitivity reaction to device materials, contrast media, medications, or direct toxic effect of contrast media on kidney function, Pacemaker syndrome, Inability to interrogate or program the LP due to programmer or LP malfunction, Intermittent or complete loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the LP (non-battery related), Loss of capture or sensing due to embolization or fibrotic tissue response at the electrode, Increased capture threshold, Inappropriate sensor response, Interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic, Battery malfunction/ premature battery depletion, Device-related complications (Premature deployment, Device dislodgement/embolization of foreign material, Helix distortion), Death. As with any percutaneous catheterization procedure, potential complications include, but are not limited to: Vascular access complications; such as perforation, dissection, puncture, groin pain, Bleeding or hematoma, Thrombus formation, Thromboembolism, Air embolism, Local and systemic infection, Peripheral nerve damage. General surgery risks and complications from comorbidities; such as hypotension, dyspnea, respiratory failure, syncope, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death.

MAT-2306873 v2.0 | Item is approved for US Use