AVEIR^™ Leadless Pacemakers

Important Safety Information

AVEIR™ DR Dual Chamber Leadless Pacemaker System

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 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, or chronic atrial fibrillation. 

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 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:

• In patients with an implanted inferior vena cava filter, femoral access is contraindicated.

• In patients with an implanted superior vena cava filter, internal jugular access is contraindicated.

• Use is contraindicated in patients with a mechanical tricuspid valve because of interference between this device and the delivery system during implantation.

• In patients who are known to be hypersensitive to device material components or a single dose of 1.0 milligram of dexamethasone sodium phosphates.

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 arrhythmias; Carotid artery injury; Cardiac perforation; Cardiac tamponade; Cerebrovascular accident (CVA); Death; Diaphragmatic/phrenic nerve stimulation/extra-cardiac stimulation; endocarditis; Heart failure; Hypotension; Hypersensitivity reaction to device materials, contrast media, or medications; Infection; Pacemaker syndrome; Palpitations; Pericardial effusion; Pericarditis; Pneumothorax/Hemothorax; RV-pacing induced cardiomyopathy; Syncope; Thoracic/lymphatic duct injury; Valve damage or regurgitation. Adverse device effects include the following: Battery malfunction/premature battery depletion; Corrupted, intermittent, or loss of i2i™ communication; Device dislodgement; Embolization of foreign material; Helix distortion; Inadequate fixation during implant with or without device migration (Intra-procedural); Inability to interrogate or program the LP due to programmer or LP malfunction; Inability to release/re-dock of the LP from catheter; Inappropriate sensor response; Increased capture threshold (Exit block, High-impedance, Threshold elevation); Intermittent or complete loss of capture, pacing or sensing (non-battery related); Interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic; Mechanical malfunction of the LP (non-battery related); Oversensing; Premature deployment; Undersensing. As with any percutaneous catheterization procedure, potential complications include, but are not limited to: Air embolism; Bleeding or hematoma; General procedural risks and complications from comorbidities, including but not limited to anesthetic complications, dyspnea, respiratory failure, syncope, pneumonia, hypertension, hypotension, cardiac failure, kidney failure due to reaction to contrast media, pain and anemia; Local and systemic infection; Peripheral nerve damage; Thrombus formation; Thromboembolism; Vascular access complications, such as arteriovenous fistula, pseudoaneurysm, perforation, dissection, puncture, venous occlusion.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse events.

™ Indicates a trademark of the Abbott group of companies. 

^‡ Indicates a third-party trademark, which is property of its respective owner.