The Heart Rhythm Society’s (HRS) 2023 conference, held in New Orleans from May 19th to 21st, brought together professionals from around the globe for an engaging and eventful weekend. Here, we present a recap of the groundbreaking scientific advancements, technological innovations, and life-saving therapies discussed during the event. These collective efforts drive us closer to our shared goal of enhancing the care provided to arrhythmia patients.
Watch highlights in electrophysiology studies on day two including the late-breaking clinical trial data on leadless technology.
Our team’s commitment to ongoing enhancement in the pursuit of keeping hearts healthy took center stage at our lively booth. Visitors had the opportunity for hands-on experience with our industry-leading technology, including:
The AVEIR™ DR Dual Chamber Leadless Pacemaker System with two distinct devices – one designed for the right atrium and the other designed for the right ventricle. It is the world’s first dual chamber leadless pacemaker system1 and provides beat-to-beat synchrony through an upgradeable system2 that is designed for long-term retrieval.4 View the late-breaking clinical trial data in the New England Journal of Medicine or discover more abour AVEIR LP technology.
We are thrilled to announce the AVEIR™ DR Dual Chamber Leadless Pacemaker System has received FDA approval since the HRS event.1
The Assert-IQ™ Insertable Cardiac Monitor (ICM) with advanced algorithms and intelligent patient insights to deliver clinically actionable data, all on the longest lasting Bluetooth® battery.† It is a next generation device that captures clear ECG/EKG signal quality, new IQ Insights to enable more informed decision making, and remote programming to reduce clinic workflow burden.** The new ICM received FDA clearance just in time for day one of the conference.
Catch up on the sessions you couldn’t attend! Register for access to our 2023 on-demand content.
We look forward to seeing you at the next HRS event.
™ Indicates a trademark of the Abbott group of companies.
†As of 12.31.22. Reveal LINQ‡ User Manual, LINQ II‡ User Manual, Lux Dx‡ User Manual, Biomonitor III‡ User Manual, Biomonitor IIIm‡ User Manual
**IQ insights and remote programming available on DM5300/DM5500.
‡ Indicates a third-party trademark, which is property of its respective owner.
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
REFERENCES
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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, Endocarditis, 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 the 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.
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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 for Use: The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses.
The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use.
Intended Use: The Assert-IQ ICM is intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.
Contraindications: There are no known contraindications for the insertion of the Assert-IQ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: allergic reaction, bleeding, chronic nerve damage, erosion, excessive fibrotic tissue growth, extrusion, formation of hematomas or cysts, infection, keloid formation and migration.
Refer to the User’s Manual for detailed indications for use, contraindications, warnings, precautions and potential adverse events.
An Abbott mobile transmitter is available for patients without their own compatible mobile device.
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The Aveir™ Leadless Pacemaker system is indicated for patients with significant bradycardia and:
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. 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.
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. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target patient population.
The Aveir™ Delivery Catheter system 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.
Use of the Aveir™ Leadless Pacemaker is contraindicated in these cases:
Potential complications associated with the use of the Aveir™ Leadless Pacemaker system are the same as with the use of single chamber pacemakers with active fixation pacing leads including, but not limited to: cardiac tamponade, diaphragmatic/phrenic nerve stimulation, device embolism, air embolism, perforation, excessive bleeding, induced ventricular arrhythmias, infection, interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic, 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, valve damage, pneumothorax/ hemothorax, inability to interrogate or program the LP due to programmer or LP malfunction, thrombosis, pericardial effusion, increased capture threshold.
As with any percutaneous catheterization procedure, potential complications include, but are not limited to: thromboembolism, air embolism, local and systemic infection, arterial puncture, bleeding or hematoma at puncture site, perforation (femoral vein or other structures), thrombus formation, embolization of the LP, venous dissection (femoral vein or other structures)
MAT-2308033 v2.0
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