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SETTING THE PACE WITH DUAL CHAMBER LEADLESS PACING AVEIR-DR-BrochureAVEIRTM DR DUAL CHAMBER LEADLESS PACEMAKER SYSTEM
SETTING THE PACE WITH DUAL CHAMBER LEADLESS PACING
INTRODUCING THE WORLD'S FIRST DUAL CHAMBER LEADLESS PACEMAKER SYSTEM1
The AVEIRTM DR Leadless Pacemaker (LP) System is a first-of-its kind, dual chamber leadless pacing system featuring:
TWO DISTINCT DEVICES Each specifically designed for the right atrium or right ventricle.
IN BOTH CHAMBERS Sensing and pacing in both the right atrial and right ventricular chambers.
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INTRODUCTION
LEADLESS ADVANTAGE
UPGRADEABLE SYSTEM
CLINICAL OUTCOME
FOR ATRIOVENTRICULAR (AV) SYNCHRONY Made possible through proprietary implant-to-implant (i2iTM) communication.
WITH AAIR, VVIR & DDDR OPTIONS Match your patients' pacing needs and upgrade over time as those needs change.
ELECTRICAL MAPPING PRIOR TO FIXATION Reduces the number of repositioning attempts to find your optimal implant site.
LONG-TERM RETRIEVAL2 No hardware is left behind to provide options for future patient needs or therapies.
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CATHETERS
WORKFLOW
MRI SCANS
THE LEADLESS ADVANTAGE
All the clinical benefits of traditional dual chamber pacemakers without associated lead and pocket-related complications including infection, lead fracture, insulation problems, skin erosion, keloid formation and no visible scarring or movement restrictions.
THE WORLD'S FIRST AND ONLY ATRIAL DEVICE1
AVEIRTM AR Atrial LP
1. Docking button 2. Outer fixation helix 3. Inner helix tip electrode
Length: 32.2 mm Diameter: 6.5 mm
The atrial device has an additional inner-helix that acts as an electrode for pacing and sensing while also designed to provide extra anchoring and stability in the atrium.2
THE VENTRICULAR DEVICE
AVEIRTM VR Ventricular LP
1. Docking button
2. Fixation helix and distal dome tip electrode (not pictured)
Length: 38.0 mm Diameter: 6.5 mm
LEADLESS ADVANTAGE
BEAT-TO-BEAT SYNCHRONY
AVEIRTM DR Leadless Pacemaker System is capable of pacing and sensing in both chambers through the combination of an atrial leadless pacemaker (AVEIRTM AR LP) and a ventricular leadless pacemaker (AVEIRTM VR LP).
Dual chamber, leadless synchronous pacing between the atrium and the ventricle is made possible with industry-first, proprietary implant-to-implant (i2iTM) communication technology capable of providing true DDDR pacing for continuous, atrioventricular (AV) synchrony, regardless of patient posture.3,4
95%
Mean AV synchrony observed for multiple postures and gaits
(including sitting, supine, left lateral recumbent, right lateral recumbent, standing, normal walking and fast walking).3
i2iTM TECHNOLOGY
To support the dual chamber therapy, each implant communicates beatto-beat with a paired, co-implanted device. 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.
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UPGRADEABLE SYSTEM4
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.
OPTION TO START WITH VENTRICULAR PACING Treat patients for rare intermittent A-V block today.
ADD ATRIAL PACING LATER Treat those same patients by adding an atrial device if sick sinus syndrome develops later to provide DDDR therapy.
ACHIEVE DUAL CHAMBER PACING Now you have options to adapt to patient needs over time.
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LONG-TERM R E T R I E VA L 2
This allows for the replacement of the atrial or ventricular device at end of service (EOS) without leaving hardware behind.
UPGRADEABLE SYSTEM
The AVEIRTM VR ventricular leadless pacemaker predicate device has a long-term retrieval success rate above 88% with helix fixation through 9 years regardless of implant duration.2
The custom designed retrieval catheter provides added confidence and is supported by a step-by-step retrieval protocol.5 AVEIRTM devices have an active fixation design that uses a screw-in mechanism to enable both implantation and long-term retrieval of the atrial and ventricular devices.4
RETRIEVAL SUCCESS BY IMPLANT DURATION2
100%
86% 50%
94%
82%
95%
77%
85%
100%
0%
0-1 Year 1-2 Year 2-3 Year 3-4 Year 4-5 Year 5-6 Year >=6 Year (n=27) (n=49) (n=54) (n=39) (n=31) (n=20) (n=20)
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PROVEN CLINICAL OUTCOME3
The following safety and efficacy results were observed at the three-month follow-up of the AVEIRTM DR i2iTM IDE study as cited in the New England Journal of Medicine.
DUAL CHAMBER PROCEDURE SUCCESS RATE OF
98.3%
95%
Mean AV synchrony observed for multiple postures and gaits
(including sitting, supine, left lateral recumbent, right lateral recumbent, standing, normal walking and fast walking).3
90.3%
90.2%
of patients were FREE FROM DEVICE or procedural related COMPLICATIONS.
of patients met the atrial device's ELECTRICAL PERFORMANCE ENDPOINT (pacing
capture threshold,
p-wave amplitude).
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CLINICAL OUTCOME
MAPPING PRIOR TO FIXATION4
Electrical mapping prior to fixation is designed to help reduce the number of repositioning attempts in the atrium and ventricle.3,4 AVEIRTM Leadless Pacemakers can assess current of injury via Commanded EGM, initial pacing capture thresholds, sensing amplitudes, and impedance in both atrial and ventricular chambers.4
of patients had successful VENTRICULAR IMPLANTS WITH 1 OR LESS REPOSITIONING ATTEMPTS.3
of patients had successful ATRIAL IMPLANTS WITH 1 OR LESS REPOSITIONING ATTEMPTS.3
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DELIVERY & RETRIEVAL C AT H E T E R S 4, 5
Designed for ergonomic, single operator use. Steerable delivery catheter with deflection mechanism. Hydrophilic coating on introducer sheath and a choice of 30 cm and 50 cm lengths.6 Protective sleeve fully covers the LP's helix during catheter navigation to reduce risk of damaging the helix or an injury to cardiovascular structures.
AVEIRTM Delivery Catheter Handle
AVEIRTM Retrieval Catheter Handle
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Delivery Catheter
Misaligning and aligning the ends of the tethers
allows for the loading and release of the pacemaker.
Retrieval Catheter Tri-Loop Snare
CATHETERS
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WORKFLOW4
The AVEIRTM DR Dual Chamber Leadless Pacemaker System implant procedure.
Scan to view the single chamber implant procedure workflow.
1
PREP the patient's skin and apply EKG electrodes. Connect to the MerlinTM Programmer via the EKG cable and AVEIR Link Module.
2
After gaining femoral vein access and visualizing the heart's anatomy and size via imaging, INSERT delivery catheter with attached ventricular leadless pacemaker. Navigate to right ventricle and map for ideal implant site FIXATE ventricular leadless pacemaker, go into tether mode to assess electrical measurements release, and then withdraw the delivery catheter.
For a more detailed workflow, refer to the AVEIRTM DR Instructions For Use (IFU) or contact your Abbott Sales Representative for training.
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3
Load the atrial leadless pacemaker onto a new delivery catheter, INSERT and navigate to right atrium and map for ideal implant site.
4
FIXATE atrial leadless pacemaker, go into tether mode to assess electrical measurements, finalize atrial device.
5
PAIR devices via i2iTM technology, assess i2iTM communication between the two pacemakers, and program dual chamber or an appropriate mode.
6
RELEASE atrial device, remove delivery catheter and close access.
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WORKFLOW
ENABLING SAFE MRI SCANS
AVEIR leadless pacemakers are MR Conditional for full body scans using a 1.5T or 3T field strength MRI scanner.
AVEIR LP MR CONDITIONAL FEATURES*
MAGNET (TESLA)
1.5T AND 3T
SCAN TYPE SCANNER MODE
FULL-BODY
FIRST LEVEL CONTROLLED OPERATING MODE OR NORMAL OPERATING MODE
MODEL NUMBERS
MODEL NUMBER DESCRIPTION
GTIN**
LSP201A LSP202V LSCD201
AVEIRTM Leadless Pacemaker (Right Atrial)
AVEIRTM Leadless Pacemaker (Right Ventricular)
AVEIRTM Delivery Catheter
05415067040701 05415067040725 05415067038487
LSCR111
AVEIRTM Retrieval Catheter
05415067034496
LSN25501
AVEIRTM Introducer - 50 cm
05415067034847
LSN25301
AVEIRTM Introducer - 30 cm
05415067034823
* For additional information about specific MR Conditional details, 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
** the leading "Os" are required for GINs
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REFERENCES:
1. AVEIRTM DR FDA Approval.
2. 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.
3. Knops, Reinoud E., et al. "A Dual-Chamber Leadless Pacemaker." New England Journal of Medicine (2023). DOI: 10.1056/NEJMoa2300080
4. AVEIRTM Leadless Pacemakers and Delivery Catheter IFU, ARTEN600284235.
5. AVEIRTM Retrieval Catheter IFU. ARTMT600174816.
6. AVEIRTM Introducer IFU. ARTEN600174817.
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
· 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.
Indications: The AVEIRTM 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 AVEIRTM 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 AVEIRTM 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 AVEIRTM 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.
· 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 AVEIRTM 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.
TM Indicates a trademark of the Abbott group of companies.
Indicates a third-party trademark, which is property of its respective owner.
MRI SCANS
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POWERING HEARTS BEAT TO BEAT
Partnering with you to personalize care from diagnosis through treatment and ongoing management.
AVEIRTM DR DUAL CHAMBER LEADLESS PACEMAKER SYSTEM. ONLY FROM ABBOTT.
Contact your Abbott Sales Representative or visit Cardiovascular.Abbott/AVEIRDR
Abbott 15900 Valley View Court, Sylmar, CA 91342 Tel: +1 818 362 6822 Abbott.com © 2023 Abbott. All Rights Reserved. MAT-2306593 v4.0 | Item approved for U.S. use.
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