Abbott AVEIR Leadless Pacemaker System
Product and reimbursement details
| Product | AVEIR™ AR Leadless Pacemaker (LP) System |
|---|---|
| Intended use (summary) | Bradycardia pacing via a pulse generator with built-in battery and electrodes implanted in the right ventricle and the right atrium; sensing of intrinsic cardiac signals and delivery of pacing therapy in the implanted chamber; optional co-implantation with another LP for dual-chamber pacing. |
| Delivery catheter intended use (summary) | Used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP, including implanting an LP within a target heart chamber. |
| Rx status | Rx Only |
| Effective date for OPPS APC change | April 1, 2026 |
| AVEIR AR LP CPT® code | 0823T |
| AVEIR AR LP Upgrade CPT® code | 0796T |
| OPPS APC change (effective April 1, 2026) | APC 5224 → APC 5231 for AVEIR AR LP (0823T) and AVEIR AR LP Upgrade (0796T) |
| New national unadjusted OPPS rate (APC 5231) | $22,725 (up from $19,679) |
| Increase magnitude | + $3,046 per case (+15.5%) |
| Comparison note in text | Ventricular leadless pacemakers continue to be assigned to APC 5224 under OPPS with a national payment rate of $19,679. |
Description
- The AVEIR Dual Chamber (DR) leadless pacing system was designed and developed by Abbott, a US-based medical device company, to treat abnormal or slow heart rhythms.
- The pacemaker received US Food and Drug Administration (FDA) approval in July 2023 and is recommended for the management of one or more chronic conditions, including syncope, pre-syncope, fatigue and disorientation.
- Abbott received the CE mark for the pacemaker in Europe in June 2024. The device was launched in Canada in August 2024, followed by the UK in November 2024 and India in October 2025.
AVEIR DR leadless pacemaker design and details
- The AVEIR DR leadless pacemaker comprises two approved single chamber devices, namely the AVEIR ventricular (VR), which paces the right ventricle, and the AVEIR atrial (AR), which paces the right atrium.
- It is attached to the heart’s interior surface using a screw-in mechanism called a helix. The mechanism allows the system to be retrieved in the future, or if the therapy requirements evolve or the device needs to be replaced.
- The AVEIR VR device is 38mm (0.12ft) long and has a diameter of 6.5mm. It comprises a docking button, a fixation helix and a distal dome tip electrode.
- The AVEIR AR device is 32.2mm long and has a diameter of 6.5mm. It includes a docking button, outer fixation helix and an inner helix top electrode, which functions as the pacing and sensing electrode, and is engineered to enhance anchorage and improve stability within the atrium.
- Abbott’s first-of-its-kind proprietary implant-to-implant (i2i) technology in the system allows beat-to-beat communication and synchronisation between the two leadless pacemakers, according to the patient’s clinical requirement, offering them dual-chamber leadless pacing therapy.
- The devices are inserted into the vein using steerable catheters incorporating an integrated deflection system. The introducer sheaths feature a hydrophilic coating and are available in 30cm or 50cm lengths.
- Offsetting or bringing the tether ends of the delivery catheter into line enables the pacemaker to be loaded into the system and subsequently deployed.
- A full-length protective sleeve encloses the helix during catheter manoeuvring, helping to minimise the chance of helix damage or trauma to cardiovascular anatomy.
- The retrieval catheter features a tri-loop snare design for device recapture.
- The pacemaker is conditionally safe for use in the magnetic resonance imaging (MRI) environment when used according to the directions in the MRI-ready leadless system manual.
Features
- The AVEIR DR pacemaker, integrated with battery and electrodes for implantation in the right ventricle and/or right atrium, provides bradycardia pacing as a pulse generator within the implanted chamber after sensing intrinsic cardiac signals.
- It can also be used in combination with a different co-implanted leadless pacemaker to offer dual chamber pacing treatment. The pacemaker is slimmer and smaller than a AAA battery.
- The system is also designed to analyse the pacing in real time, enabling physicians to assess the correct placement of the device inside the heart chamber during the procedure.
Technology details of the AVEIR DR
- Abbott’s i2i communication technology makes use of high-frequency pulses to transmit messages through the natural conductive properties of the bloodstream, connecting each leadless pacemaker.
- Each implant communicates with a paired, co-implanted device in a coordinated manner to support dual-chamber therapy.
- Conductive communication is crucial because it uses much less battery current than inductive, radio frequency or Bluetooth communications, the other options used in conventional pacemakers or other implantable medical devices.
Clinical trials of AVEIR
- FDA approval of the AVEIR DR leadless pacemaker device was based on the results of a prospective, multi-centre, international, single-arm and pivotal AVEIR DR i2i Investigational Device Exemption (IDE) clinical trial.
- The clinical trial evaluated the safety and performance of the pacemaker with three predetermined primary endpoints.
- The first 300 patients were enrolled in the trial across 55 locations in the US, Canada and Europe. The design objectives of AVEIR DR include technologies that enable true dual-chamber leadless pacing by regulating the heart rate simultaneously and continuously between both chambers.
- The AVEIR DR i2i IDE study results showed a 98.3% implant success rate, while more than 97% of patients had successful atrioventricular (AV) synchrony through three months post-implantation.
- AV synchrony occurs when the heart’s upper and lower chambers beat normally, regardless of the underlying slow heart rhythms.
- In each of the seven different postures and walking speeds, patients exhibited an average AV synchrony of more than 95%, indicating the pacemaker’s suitability for performing effectively during daily life activities.
Benefits of leadless pacemakers
- Unlike conventional pacemakers, leadless pacemakers are inserted directly into the heart via a minimally invasive procedure and do not require cardiac leads and a pulse generator under the skin.
- Leadless pacemakers, therefore, lower people’s exposure to potential lead and infection-related issues while also providing a less constrained and shorter post-implantation recovery time.
- Abbott’s AVEIR DR leadless pacemaker system, which is approximately one-tenth the size of a conventional pacemaker, offers a new minimally invasive alternative to treat people with slow or aberrant heart rhythms.
Contraindications (examples listed in the provided text):
use is contraindicated with a co-implanted ICD (high-voltage shocks); single-chamber ventricular demand pacing in patients with pacemaker syndrome, retrograde VA conduction, or drop in arterial blood pressure with onset of ventricular pacing; programming rate-responsive pacing in patients intolerant of high sensor-driven rates; implantation with an implanted vena cava filter or mechanical tricuspid valve due to interference with the delivery system during implantation; known history of allergies to components of the device (counseling and allergy history required). Potential percutaneous catheterization complications are also listed (e.g., vascular access complications, bleeding/hematoma, thrombus/thromboembolism, infection, nerve damage, sedation reactions, renal failure, anemia, death), with direction to the User’s Manual for detailed information.
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 for Use
The AVEIR Leadless Pacemaker system is indicated for management of one or more of the following chronic clinical presentations: syncope, pre-syncope, fatigue, disorientation, and one or more of the indications which follow. 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 one or more of the following conditions: 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. 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 the 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; endocarditis; thrombus formation; thromboembolism; valve damage 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 capture, pacing or sensing (non-battery related); oversensing; increased capture threshold; inappropriate sensor response; corrupted, intermittent, or loss of i2i communications; 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, inability to release/re-dock of the LP from catheter, helix distortion); additional surgery or intervention; 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 dyspnea, respiratory failure, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse events.
Disclaimer:
This material and the information contained herein is for general information purposes only and is not intended, and does not constitute, legal, reimbursement, business, clinical, or other advice. Furthermore, it is not intended to and does not constitute a representation or guarantee of reimbursement, payment, or charge, or that reimbursement or other payment will be received. It is not intended to increase or maximize payment by any payer. Abbott makes no express or implied warranty or guarantee that the list of codes and narratives in this document is complete or error-free.
Similarly, nothing in this document should be viewed as instructions for selecting any particular code, and Abbott does not advocate or warrant the appropriateness of the use of any particular code. The ultimate responsibility for coding and obtaining payment/reimbursement remains with the customer. This includes the responsibility for accuracy and veracity of all coding and claims submitted to third-party payers.
In addition, the customer should note that laws, regulations, and coverage policies are complex and are updated frequently, and, therefore, the customer should check with its local carriers or intermediaries often and should consult with legal counsel or a financial, coding, or reimbursement specialist for any questions related to coding, billing, reimbursement, or any related issues. This material reproduces information for reference purposes only. It is not provided or authorized for marketing use.
CAUTION:
Product(s) intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at www.eifu.abbott for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Troubleshooting
| Problem | Possible Cause | Solution |
|---|---|---|
| Dizziness or fainting after implantation | Rhythm problem, pacing issue, or unrelated medical condition | Contact the treating cardiac team promptly for assessment |
| Unusual heartbeat sensation | Rhythm change or pacing-related event | Report symptoms to the cardiologist and arrange device evaluation |
| Device cannot be interrogated normally | Communication, programming equipment, or device issue | Have qualified clinical personnel evaluate the system |
| Unexpected pacing measurements | Device position, tissue interface, or physiological change | Clinical assessment and device interrogation are required |
| Reduced pacing effectiveness | Changes in sensing or pacing threshold | Cardiologist should evaluate and reprogram or manage the device as appropriate |
| Concern before MRI | MRI conditions have not been verified | Do not proceed until the implant and MRI requirements are checked by the appropriate medical team |
| Implant access site becomes increasingly painful or abnormal | Possible procedure-related complication | Contact the implanting medical team promptly |
| Battery approaching replacement stage | Normal long-term battery depletion | Follow the cardiologist’s recommended device-management plan |
Contact Info
Abbott 3200 Lakeside Dr., Santa Clara, CA 95054 USA Tel: 1.800.227.9902 www.cardiovascular.abbott
Documents / Resources
 | AVEIR Leadless Pacemaker System |
References
- Life-Changing Cardiac and Vascular Technology | Abbott Cardiovascularwww.cardiovascular.abbott
- Life-Changing Cardiac and Vascular Technology | Abbott Cardiovascularwww.cardiovascular.abbott
- cms.gov/medicare/regulations-guidance/transmittals/2026-transmittals/r13686cpwww.cms.gov
- cms.gov/medicare/regulationsguidance/transmittals/2026-transmittals/r13686cpwww.cms.gov
- User Manualmanual.tools
J’ai ete implanté ( à l’hopital Pompidou de Paris) avec cune stimulateur cardiaque sans sonte atrial de marque ABBOTT type AVEIR-A.
Je dois passer une IRM cerebrale aussitot que possible.
L’hopital qui pourrait le faire me demande le manuel pour ce pacemaker, et en particulier le mode operatoire pour effectuer cet IRM. Merci de votre reponse en urgence. Trés cordialement.
Jacques BOGAERT
Je dois passer une IRM cerebrale aussitot que possible.
L'hopital qui pourrait le faire me demande le manuel pour ce pacemaker, et en particulier le mode operatoire pour effectuer cet IRM. Merci de votre reponse en urgence. Trés cordialement.
Jacques BOGAERT
Where can I find the MRI safety manual and operating procedures for the Abbott AVEIR-A leadless pacemaker?
The Abbott AVEIR Leadless Pacemaker (LP) System is classified as MR Conditional. This means it is safe for use in an MRI environment, but only when specific conditions are met according to the manufacturer's protocols.
To provide the hospital with the necessary documentation, you should access the official MRI-Ready Leadless System Manual. Abbott provides these technical manuals and Instructions for Use (IFU) through their dedicated eLabeling portal:
Important Note: The pacemaker must be programmed to a specific "MRI Mode" by a qualified clinician or technician before you enter the MRI scanner room, and it must be checked again after the scan is complete. You should contact your cardiology team at Hôpital Pompidou to ensure they coordinate with the imaging center to set the device to the correct mode for your procedure.
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