Abbott AVEIRTM AR Right Atrial Leadless Pacemaker System Instructions
- September 23, 2024
- Abbott
Table of Contents
- Abbott AVEIRTM AR Right Atrial Leadless Pacemaker
- Specifications
- TERMS AND CONDITIONS
- PACEMAKERS MEDICARE REIMBURSEMENT
- MEDICARE COVERAGE
- FAQs
- Right Atrial LP System Category
- SAMPLE CMS 1500 FORM
- IMPORTANT SAFETY INFORMATION
- CONTACT INFORMATION
- References
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
Abbott AVEIRTM AR Right Atrial Leadless Pacemaker
Specifications
- Product Name: AVEIRTM AR Right Atrial Leadless Pacemaker System
- Type: Right Atrial pacing system
- Implantation: Percutaneous delivery via femoral vein
- Components: Includes AVEIRTM Introducer and Delivery Catheter
- Features: Leadless design, no connector, pacing lead, or pulse generator pocket needed
FAQs 1. What is the purpose of the AVEIRTM AR Right Atrial Leadless Pacemaker System? The system is designed to provide right atrial pacing without the need for traditional connectors, pacing leads, or pulse generator pockets. 2. How is the pacemaker system implanted?
The system is implanted percutaneously through the femoral vein using the provided AVEIRTM Introducer and Delivery Catheter.
3. How can healthcare professionals access reimbursement support?
Healthcare professionals can contact Abbott’s reimbursement hotline for live coding and reimbursement information.
4. What should be done post-implantation of the pacemaker system?
Patients should be monitored for any complications, and appropriate post- operative care should be provided as needed.
TERMS AND CONDITIONS
All content herein may be based upon several sources, including but not limited to primary sources, scientific literature, commercially available data sets, customer-supplied information, and external sources. The estimates shown are for illustrative purposes only. This content is not intended for any other purpose. It should be noted that there are usually differences between economic modeling actual results. Abbott does not take responsibility for any such discrepancies. There is no guarantee of any potential economic outcome, including payment, cost savings, or procedure volume. Economic outcomes are dependent on many factors and will vary. Certain Maryland hospitals paid under Maryland Waiver provisions using All Patient Refined Diagnosis Related Group (APR-DRG) are excluded from payment under the Medicare Inpatient Prospective Payment System (IPPS). Reimbursement Calculators should not be provided at no charge to actively licensed Healthcare Professionals (HCPs) who regularly practice in Vermont. This information is not to be distributed to third parties.
PACEMAKERS MEDICARE REIMBURSEMENT
AVEIR™ AR Right Atrial Leadless Pacemaker System Introduction
The AVEIR™ AR Right Atrial Leadless Pacemaker (LP) System is a right atrial pacing system implanted in a patient’s right atrial chamber of the heart. As a leadless pacemaker system, the AVEIR™ AR Right Atrial LPs do not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIR™ Introducer and Delivery Catheter.
Reimbursement Hotline
Abbott offers a reimbursement hotline, which provides live coding and reimbursement information from dedicated reimbursement specialists. Coding and reimbursement support is available from 8 a.m. to 5 p.m. Central Time, Monday through Friday at 855-569-6430 or HCE@abbott.com. Coding and reimbursement assistance is provided subject to the disclaimers set forth in this content.
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 the 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.
MEDICARE COVERAGE
LEADLESS PACEMAKER THERAPY
The leadless pacemaker procedure using AVEIR™ AR Right Atrial Leadless Pacemaker System is approved by CMS under a claims analysis study that will passively collect and analyze real-world data to demonstrate the role of the therapy in patients that need a pacemaker. View NCD: Leadless Pacemakers (20.8.4) for more information https://www.cms.gov/medicare-coverage- database/view/ncd.aspx?NCDId=370. A Leadless Pacemaker must be used in accordance with the FDA-approved label for the device. It is the responsibility of the physician to determine whether the procedure meets the criteria for coverage and to confirm use in accordance with approved labeling. It is the responsibility of the physician to diagnose and treat the patient and to confirm coverage, coding and claim submission guidance with the patient’s health insurance plan to ensure claims are accurate, complete, and supported by documentation in the patient’s medical record.
MEDICARE CLAIM FORM INSTRUCTIONS
The physician is responsible for determining whether the procedure meets the criteria for coverage and confirming use in accordance with approved labeling. It is the responsibility of the physician to diagnose and treat the patient and to confirm coverage, coding and claim submission guidance with the patient’s health insurance plan to ensure claims are accurate, complete, and supported by documentation in the patient’s medical record.
CLAIMS IDENTIFYING INFORMATION TO SIGNIFY PATIENT IS PARTICIPATING IN A STUDY|
PROFESSIONAL CLAIM FORM (CMS 1500-837P)
|
INSTITUTIONAL CLAIM FORM (UB-04-837i)
---|---|---
National Clinical Trial (NCT) Number| 06100770 (For paper claims, Report:
CT06100770)| 06100770
Condition Code 30| Not reported on Physician Claim| 30
Secondary Diagnosis Code
| Z00.6 (Encounter for examination for normal comparison and control in clinical research program)| Z00.6 (Encounter for examination for normal comparison and control in clinical research program)
Q0 Modifier
| Q0 (Investigational clinical service provided in a clinical research study
that is an approved clinical research study)| Q0 (Investigational clinical
service provided in a clinical research study that is an approved clinical
research study)
Value codes| Not applicable| D4 (“code”) and NCT number (“amount”)
FAQs
COVERAGE WITH EVIDENCE DEVELOPMENT FREQUENTLY ASKED QUESTIONS (FAQs)
These FAQs are intended for general informational purposes only to help provide information that may assist in understanding of Medicare’s Coverage with Evidence Development (CED) Study policy relating to the AVEIR™ AR Right Atrial Leadless Pacemaker System when used in accordance with its FDA approved labeling. Physician is responsible for determining whether the procedure meets the criteria for coverage and confirming use in accordance with approved labeling. It is the responsibility of the physician to diagnose and treat the patient and to confirm coverage, coding and claim submission guidance with the patient’s health insurance plan to ensure claims are accurate, complete and supported by documentation in the patient’s medical record.
| FAQ | WHAT DOES THIS MEAN FOR MY HOSPITAL? |
|---|
Is AVEIR ™ AR Right Atrial LP covered by CMS?
The Centers for Medicare and Medicaid has a National Coverage Determination for leadless pacemakers, Policy 20.8.4. This is a CED policy that is applicable to all leadless pacemaker procedures for all Medicare beneficiaries, including Medicare fee-for-service and Medicare Advantage. As part of the coverage criteria, CMS requires all patients to be included in a CMS-approved study. Abbott has a real-world study for AVEIR™ AR Right Atrial LP, and AVEIR™ AR Right Atrial LP CED study to meet these coverage requirements and has obtained approval. The AVEIR™ AR Right Atrial LP CED study has a clinical trial number to be utilized only for patients indicated for AVEIR™ AR Right Atrial LP.
|
Medicare coverage is now available for AVEIR™ AR Leadless Pacemaker implant procedures for any Medicare beneficiaries indicated for a leadless pacemaker and included in the AVEIR™ AR Right Atrial LP CED study.
How do I report that the AVEIR ™ AR Right Atrial LP patient is part of a CMS-approved study?
Under the CMS CED policy, CMS requires that you report a National Clinical Trial number on the applicable claim. The NCT number for the AVEIR™ AR Right Atrial LP CED study is
NCT06100770.
|
The inclusion of the AVEIR™ AR Right Atrial LP CED study NCT number (NCT 06100770) is required for CMS coverage purposes.
Is the AVEIR ™ AR Right Atrial LP CED study the same as AVEIR ™ AR’s Leadless Pacemaker FDA post-approval study (PAS)?
No. They are two separate studies with two different NCT numbers. The AVEIR™ AR Right Atrial LP CED study study is a CMS-approved CED Study that is required for CMS coverage. The PAS is a predetermined group of sites participating in a registry that was established to
meet post-approval FDA requirements, independent from the CED study.
|
The NCT number (NCT 06100770) assigned to the AVEIR™ AR Right Atrial LP CED study is unique to the AVEIR™ AR Leadless Pacemaker. The inclusion of the unique AVEIR™ AR Right Atrial LP CED study NCT number (NCT 006100770) is a requirement for CMS coverage for AVEIR™ AR LP procedures.
| FAQ | WHAT DOES THIS MEAN FOR MY HOSPITAL? |
|---|
Does my hospital’s Institutional Review Board (IRB) need to approve the AVEIR ™ AR Right Atrial LP CED study?
The AVEIR™ AR Right Atrial LP CED study involves CMS claims or clinical data that are collected in the context of healthcare delivery, and the data collection involves no direct patient contact and will not influence the care a patient receives during routine interactions with the healthcare system. Therefore, IRB approvals are unlikely to be required by the hospital. Abbott, being the main entity in the AVEIR™ AR Right Atrial LP CED study, has requested and been granted a waiver of informed consent and a HIPAA waiver from Western IRB. The Council for International Organizations of Medical Sciences (CIOMS), in a publication issued jointly with the World Health Organization (WHO), has stated that a waiver of the informed consent requirement may be granted by an IRB, “when the research design involves no more than minimal risk and a requirement of individual informed consent would make the conduct of the research impracticable (for example, where the research involves only excerpting data
from subjects’ records)”. (Data on file at Abbott)
|
It is unlikely an IRB approval would be required by the hospital. We recommend that you review the hospital’s policies and procedures along with this information.
Is the AVEIR ™ AR Right Atrial LP CED study NCT number (NCT 06100770) required to be reported on private payer or Medicaid patient claims for coverage?
The NCT number (NCT 06100770) does not apply to private payers or Medicaid. The AVEIR™ AR Right Atrial LP CED study NCT number (NCT 06100770) is required for Medicare beneficiaries’ coverage only, including Fee-For-Service and Medicare
Advantage.
|
AVEIR™ AR Right Atrial LP CED study NCT number (NCT 06100770) is only required in connection with claims for coverage for Medicare beneficiaries.
Who can I contact if I have more questions?
Contact the Health Economics team at Abbott: LeadlessReimbursement@abbott.com or you can contact the reimbursement hotline, which provides live coding and reimbursement information from dedicated reimbursement specialists. Coding and reimbursement support is available from 8 a.m. to 5 p.m. Central Time, Monday through Friday at 855-569-6430
|
Please contact the Abbott team using these channels when needed.
AVEIR™ A RIGHT ATRIAL LEADLESS PACEMAKER (LP) SYSTEM
FDA approved June 29, 2023, the AVEIR™ AR Right Atrial Leadless Pacemaker (LP)
is capable of pacing and sensing in the right atrium. Atrial pacing
indications include sinus mode dysfunction and normal AV and intraventricular
conduction systems.
The American Medical Association (AMA) has approved a series of Category III
CPT‡ codes to report right atrial single chamber leadless pacemaker
procedures. The Category III CPT‡ codes became effective on January 1, 2024.
Category III CPT‡ codes are a set of temporary codes to report emerging
technology, services, and procedures. These codes are intended to be used to
track the usage of these services, and the data collected may be used to
substantiate widespread usage by the AMA. However, Category III codes are not
valued and assigned a federal physician fee schedule by CMS. This document
provides reference material related to general considerations for physician
crosswalk payment for right atrial single chamber leadless pacemaker system
procedures when performed consistent with the product’s labeling.
Reporting a Category III CPT‡ Code
Physician Services Considerations for Right Atrial Single Chamber Leadless
Pacemaker Procedures
Category III CPT‡ codes do not have an assigned payment rate (established
Relative Value Unit (RVU)) in Medicare’s physician fee schedule, and therefore
private insurers do not have assignment of RVUs to use as a basis for setting
physician payment. Since Category III CPT‡ codes do not have established RVUs,
prior authorization requests (please note that traditional Medicare does not
require prior authorization) and claims must generally be submitted with
supporting documentation and may be subject to review. Comparable Category I
CPT‡ codes that are similar to the Category III code may be identified to
provide accurate information to payers for consideration when they are
processing claims. By providing a comparable Category I CPT‡ code along with
additional documentation, payers can better understand what took place during
the procedure, and value it accordingly. Payers will review each claim with a
Category III CPT‡ code for right atrial single chamber leadless pacemaker
procedures individually, and payment determinations will be made on a case-by-
case basis. Therefore, it is strongly recommended that the provider contact
payers to ensure the new Category III CPT‡ codes are included in contracts and
to inquire about any guidelines for submission and documentation of these
claims. Recommended Supporting Documentation for Claim Submission (List is not
comprehensive; check with your applicable payer)
- A cover letter describing the services rendered and why the service was needed
- Copy of operative report that details the procedure including provider’s time and effort during procedure
- Time, effort, and equipment necessary to perform the procedure
- Include the relevant crosswalk Category I CPT‡ code for a comparable procedure while also noting any and all differences with the services provided for the right atrial
- Customized Letter of Medical Necessity for the patient receiving the procedure
- Copy of FDA Approval Letter
- Copy of published clinical data
Considerations when choosing a comparable procedure to reference in supporting documentation
Physicians are encouraged to identify comparable crosswalk Category I CPT‡ codes to reference in supporting documentation provided with the claim submission when billing for leadless pacemaker procedures. Physicians will need to document in detail the work involved with specificity of time, the complexity of the procedure, and practice expense relative to comparable procedures with established RVUs and payment amounts.
Considerations when reporting a coding crosswalk on a claim
Physicians should report the appropriate Category III CPT‡ code for the procedure and bill an amount comparable to the crosswalk code. If a comparable crosswalk includes multiple units, then the explanation line should include all activity combined into one explanation (do not enter multiple lines of crosswalk codes). An example of a crosswalk comparison is below.
Right Atrial LP System Category
AVEIR™ AR Right Atrial LP System Category III CPT‡ Codes
INSERTION
| CPT‡ CODE | DESCRIPTION | WORK RVU |
|---|
0823T
| Transcatheter insertion of a permanent single-chamber leadless pacemaker, right atrial, including imaging guidance (eg, fluoroscopy, venous ultrasound, right atrial angiography and/or right ventriculography, femoral venography, cacography) and device evaluation (eg, interrogation or programming), when performed|
N/A
REMOVAL
| CPT‡ CODE | DESCRIPTION | WORK RVU |
|---|---|---|
| 0824T | Transcatheter removal of a permanent single-chamber leadless pacemaker, |
right atrial, including imaging guidance (eg, fluoroscopy, venous ultrasound, right atrial angiography and/or right ventriculography, femoral venography, cacography), when performed| N/A
REMOVAL & REPLACEMENT
| CPT‡ CODE | DESCRIPTION | WORK RVU |
|---|
0825T
| Transcatheter removal and replacement of permanent single-chamber leadless pacemaker, right atrial, including imaging guidance (eg, fluoroscopy, venous ultrasound, right atrial angiography and/or right ventriculography, femoral venography, cacography) and device evaluation (eg, interrogation or programming), when performed|
N/A
PROGRAMMING
| CPT‡ CODE | DESCRIPTION | WORK RVU |
|---|
0826T
| Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional, leadless pacemaker system in single- cardiac chamber|
N/A
Category III Coding Crosswalk Examples
When considering comparable procedures, the following procedures may require similar effort, expertise, time, and resource utilization. It is strongly encouraged that physicians include operative notes detailing the effort and time of the procedure to support adequate reimbursement.
- (Coding options/examples presented below have been reviewed with independent consultants and certified coders).
Coding Crosswalk Options: AVEIR™ AR Right Atrial Leadless Pacemaker – Insertion
Potential CPT‡ Code Crosswalks for 0825T
CPT‡ CODE
|
DESCRIPTION
|
2024 WORK RVU
| 2024 NATIONAL MEDICARE AVERAGE
33274
| Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular, including imaging guidance (e.g., fluoroscopy, venous ultrasound, ventriculography, femoral venography) and device evaluation (e.g., interrogation or programming), when performed|
7.8
|
$461
Coding Crosswalk Options: AVEIR™ AR Right Atrial Leadless Pacemaker – Removal
Potential CPT‡ code crosswalks for 0824T
CPT‡ CODE
|
DESCRIPTION
|
2024 WORK RVU
| 2024 NATIONAL MEDICARE AVERAGE
33275| Transcatheter removal of a permanent leadless pacemaker, right
ventricular, including imaging guidance (e.g., fluoroscopy, venous ultrasound,
ventriculography, femoral venography), when performed| 8.59| $487
Category III Coding Crosswalk Examples
Coding Crosswalk Options: AVEIR™ AR Right Atrial LP System Removal & Replacement
Potential CPT‡ Code Crosswalks for 0825T
CPT‡ CODE
|
DESCRIPTION
|
2024 WORK RVU
| 2024 NATIONAL MEDICARE AVERAGE
33274
| Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular, including imaging guidance (e.g., fluoroscopy, venous ultrasound, ventriculography, femoral venography) and device evaluation (e.g., interrogation or programming), when performed|
7.8
|
$461
Coding Crosswalk Options: AVEIR AR Right Atrial Leadless Pacemaker – Programming
Potential CPT‡ Code Crosswalks for 0826T
CPT‡ CODE
|
DESCRIPTION
|
2024 WORK RVU
| 2024 NATIONAL MEDICARE AVERAGE
93279
| Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review, and report by a physician or other qualified health care professional; single lead pacemaker system or leadless pacemaker system in one cardiac chamber|
0.65
|
$66
Note : The Category I CPT‡ code represented in the above tables is provided for convenience for illustrative purposes only and is not meant to be all-inclusive. Physicians are responsible for providing all information payers may require in support of a claim including selecting the appropriate Category I CPT‡ code comparator and explaining how the work involved, including the time and complexity of the procedure and the practice expense, is similar to the procedure taking place. Please note that where a Category III CPT‡ code is available it MUST be reported. Any comparator CPT‡ code identified should be included only in the supporting documentation submitted with the claim.
SAMPLE CMS 1500 FORM
AVEIR™ AR Right Atrial LP FOR ILLUSTRATIVE PURPOSES ONLY
AVEIR™ AR RIGHT ATRIAL LEADLESS PACEMAKER (LP) SYSTEM
Hospital Inpatient 000000 – National
ICD-10 DESCRIPTION TYPICAL MS-DRG MEDICARE
PCS CODE ASSIGNMENT NATIONAL RATE
AVEIR™ AR: Insertion
02H63NZ
|
Insertion of Intracardiac Pacemaker into Right Atrium, Percutaneous Approach
| 228 with MCC| $35,279
229 without MCC| $22,262
AVEIR™ AR Removal or Revision
02PA3NZ| Removal of Intracardiac Pacemaker from Heart, Percutaneous Approach|
228 with MCC| $35,279
02WA3NZ| Revision of Intracardiac Pacemaker from Heart, Percutaneous Approach|
229 without MCC| $22,262
AVEIR™ DR: Upgrade (AR insertion/ VR existing)
X2H63V9
|
Insertion of Dual-Chamber Intracardiac Pacemaker into Right Atrium, Percutaneous Approach
| 228 with MCC| $35,279
229 without MCC| $22,262
Effective Dates: October 1, 2023 – September 30, 2024
AVEIR™ AR RIGHT ATRIAL LEADLESS PACEMAKER SYSTEM
Hospital Outpatient 000000 – National
| CPT‡ CODE | DESCRIPTION | STATUS INDICATOR | APC | MEDICARE NATIONAL RATE |
|---|
INSERTION
0823T
| Transcatheter insertion of permanent single-chamber leadless pacemaker, right atrial, including imaging guidance (eg, fluoroscopy, venous ultrasound, right atrial angiography and/or right ventriculography, femoral venography, cavography) and device evaluation (eg, interrogation or programming), when performed|
J1
|
5224
|
$18,565
REMOVAL
0824T
| Transcatheter removal of permanent single-chamber leadless pacemaker, right atrial, including imaging guidance (eg, fluoroscopy, venous ultrasound, right atrial angiography and/or right ventriculography, femoral venography, cacography), when performed|
J1
|
5183
|
$3,037
REMOVAL & REPLACEMENT
0825T
| Transcatheter removal and replacement of permanent single-chamber leadless pacemaker, right atrial, including imaging guidance (eg, fluoroscopy, venous ultrasound, right atrial angiography and/or right ventriculography, femoral venography, cacography) and device evaluation (eg, interrogation or programming), when performed|
J1
|
5224
|
$18,565
PROGRAMMING DEVICE EVALUATION
0826T
| Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional, leadless pacemaker system in single- cardiac chamber|
Q1
|
5741
|
$36
INTERROGATION
93288
| Interrogation device evaluation (in person) with analysis, review, and report by physician or other qualified healthcare professional, includes connection, recording, and connection per patient encounter; single, dual or multiple lead pacemaker system, or leadless pacemaker system|
Q1
|
5741
|
$36
Effective Dates: January 1, 2024 – December 31, 2024
- J1: Hospital Part B services paid through a comprehensive APC
- Q1: STV-Packaged Codes
AVEIR™ A RIGHT ATRIAL LEADLESS PACEMAKER (LP) SYSTEM
HCPCS Device Category C-Codes
C-CODE DESCRIPTION
AR Insertion (de novo)
C1786| Pacemaker, single-chamber rate-responsive (implantable)
C1894| Introducer/sheath, other than guiding, other than intracardiac
electrophysiological, nonlaser
AR Insertion to upgrade to DR (existing VR)
*C1889| Implantable/insertable device, not otherwise classified
*A new C-code assignment with the TPT assignment for AVEIR™ DR & AR upgrades.
ICD-10-CM (Interna onal Classifica on of Diseases, Tenth Revision, Clinical Modifica on) Diagnosis Codes
Diagnosis codes are used by both hospitals and physicians to document the indication for the procedure. For Cardiac Pacemaker, Implantable Cardioverter Defibrillator (ICD), and Implantable/Insertable Cardiac Monitors (ICM) patients, there are many possible diagnosis code scenarios and a wide variety of possible combinations. The possible scenarios and combinations are too numerous to capture in this document. The customer should check with their local carriers or intermediaries and should consult with legal counsel or a financial, coding or reimbursement specialist for coding, reimbursement or billing questions related to ICD-10-CM diagnosis codes. Diagnosis is the sole responsibility of the physician and reimbursement support provided is not intended to affect the physician’s independent clinical judgment.
Commercial (Private) Payers
Coverage for leadless pacemakers varies by payer policy. We encourage providers to contact non-Medicare payers to confirm coverage prior to performing the procedure.
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 AVEIRâ„¢ 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 AVEIRâ„¢ 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 AVEIRâ„¢ 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 AVEIRâ„¢ 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.
SAMPLE CMS 1500 FORM
AVEIR™ AR Right Atrial LP FOR ILLUSTRATIVE PURPOSES ONLY
SAMPLE CMS UB-04 FORM
VEIR™ AR Right Atrial LP FOR ILLUSTRATIVE PURPOSES ONLY
- FY2024 IPPS Final Rule Home U.S. Centers for Medicare and Medicaid Services. [cited: August 2023].
- CY2024 MPFS Final Rule HomeU.S. Centers for Medicare and Medicaid Services. [cited: November 2023].
- CY2024 OPPS Final Rule Home Page. U.S. Centers for Medicare and Medicaid Services. [cited: November 2023].
- CMS 2024 ICD-10-CM [cited: August 2023].
- Leadless Pacemakers [cited: June 2022].
- Claim Submission [cited: June 2022].
- AMA CPT‡ Category III Codes, First Ten Years [cited: January 2024]
- AMA CPT‡ Category III codes long [cited: January 2024]
- National Coverage Determination Leadless Pacemakers 20.8.4 [cited: January 2024]
- Medicare Claims Processing Manual, Chapter 32, Section 380 – Leadless Pacemakers [cited: January 2024]
- Aveir AR Coverage With Evidence Development Post-Approval Study (CED) [cited: April 2024]
- CMS 1500 Claim Form [cited: April 2024]
- CMS UB-04 Claim Form [cited: April 2024]
CONTACT INFORMATION
CAUTION : This product is 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 vascular.eifu.abbott or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions, and Adverse Events. This material is intended for use with healthcare professionals only. Information contained herein is for DISTRIBUTION in the US ONLY
Data on file at Abbott
Abbott
- One St. Jude Medical Dr., St. Paul, MN 55117, USA, Tel: 1 651 756 2000
- ™ indicates a trademark of the Abbott Group of Companies
- ‡ Indicates a third-party trademark, which is the property of its respective owner.
- www.cardiovascular.abbott
- ©2024 Abbott. All rights reserved. MAT-2201720 v11.0 | Item approved for U.S. use only.
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>