Pacemakers

A Heart Arrhythmia Treatment Solution

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What is a Pacemaker?

It's a heart rate manager.

A pacemaker is a small, battery-powered device that “listens” to your heart. If it’s beating properly, the pacemaker does nothing. But when your heart is beating too slowly, the pacemaker sends tiny electrical signals to return your heart rate to within your normal range. 

 

It can evaluate your heart.

It also records and stores information about your heart rate and any potential arrhythmias for your doctor to plan for the best treatments and therapies.

 

What are the Types of Pacemakers?

Heart illustration with pacemaker

Traditional Pacemaker with Leads

A traditional pacemaker is implanted under the skin in the chest area and connected to leads that travel down blood vessels to the heart and attach to the heart tissue. Leads are flexible, insulated wires that run between the pacemaker and the tissue of the heart. If the pacemaker senses that your heart has slowed down or missed a beat, the leads transmit electrical impulses to the heart to restore it to its normal rate. 

Heart illustration with pacemaker

Leadless Pacemaker

A leadless pacemaker functions in a similar way to control your heart rate, but achieves this in a different way. Instead of using leads, the pacemaker can sense and pace your heart through a small device implanted in your heart through a blood vessel in your leg. Unlike a traditional pacemaker, it does not have any leads or wires, and does not require a chest incision, so no scars on the chest or arm movement restrictions. 

Heart illustration with pacemaker

Leadless pacemakers are 10 times smaller than a traditional pacemaker and do not require leads.

Heart illustration with pacemaker

Hear Stories from Patients with AVEIR™ Leadless Pacemakers

What to Expect with Your Pacemaker 

Find answers to your questions about both traditional and leadless pacemakers, including the implantation procedure, safety and use, and daily living with your device.

 

 

 

What to expect with your pacemaker pdf cover

AVEIR Leadless Pacemakers

Learn about the first-of-its-kind, dual chamber leadless pacing system and Abbott’s single chamber atrial and ventricular leadless pacemakers. These leadless pacemakers feature all the clinical benefits of traditional pacemakers without lead and pocket-related complications or arm movement restrictions.

AVEIR Leadless Pacemaker pdf cover

Frequently Asked Questions

Pacing is the process in which regulating or changing the timing or intensity of your heartbeat, or cardiac contractions, are made. Depending on your symptoms and the specific heart condition, your doctor may prescribe a different type of pacemaker.

Use our list of questions to help guide a conversation with your doctor.

What is a leadless pacemaker?

A leadless pacemaker is a small, wire-free device implanted directly into the heart to regulate its rhythm. It is implanted in your heart through a blood vessel in your leg.

What is the difference between a leadless and traditional pacemaker?

Unlike traditional pacemakers, leadless pacemakers do not require electrical leads (wires) threaded through veins. Leadless pacemakers are 10 times smaller than traditional models. This design reduces complications and provides a minimally invasive implantation procedure.

Are pacemakers reliable?

Yes, pacemakers are generally considered safe and effective. They have a long history of successfully treating heart rhythm disorders and improving the quality of life for many people.

How is a leadless or traditional pacemaker implanted?

Leadless pacemakers are inserted via a catheter through a small incision in your groin and attached directly to a wall inside the heart through a minimally invasive procedure. Traditional pacemakers are surgically implanted under the skin in the chest area and connected to leads that attach to the heart wall.

What restrictions exist with a pacemaker?

With a traditional pacemaker, normal activity can resume around six weeks after implantation. Some arm movement restrictions will exist. Normal activity can resume around two weeks after implantation of a leadless pacemaker, and there are no arm movement restrictions.

 

Remote Care with Your Pacemaker

Some pacemakers use wireless remote monitoring, while others need a wand or skin electrodes for communication.

Remote monitoring allows your pacemaker to share information about your heart directly with your doctor’s office without having to go in-person. It works continuously throughout the day and night, reducing the need for in-person visits.

The Merlin@home™ transmitter syncs with your pacemaker, collecting data on your heart’s activity, including heart rate and rhythm, and shares it with your doctor for monitoring.

Indications, Safety & Warnings

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.

Leadless Pacemaker 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.

Traditional Pacemaker Indications and Usage: Implantation of a Cardiac Resynchronization Therapy Pacemaker (CRT-P) is indicated for: maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure; the reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ¢35% and a prolonged QRS duration. Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions, or any combination of these symptoms: syncope, presyncope, 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. Chronotropic incompetence has not been rigorously defined. A conservative approach, supported by the literature, defines chronotropic incompetence as the failure to achieve an intrinsic heart rate of 70% of the age-predicted maximum heart rate or 120 bpm during exercise testing, whichever is less, where the age-predicted heart rate is calculated as 197 — (0.56 x age). Dual-chamber pacing (dual-chamber pulse generators, CRT-Ps) is indicated for those 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. AF Suppression™ algorithm (dual-chamber pulse generators, CRT-Ps) stimulation is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

Leadless Pacemaker 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.

Leadless Pacemaker 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.

Traditional pacemaker Contraindications: Single-chamber pulse generators, dual-chamber pulse generators, and CRT-Ps are contraindicated in patients with an implanted cardioverter-defibrillator. Rate-adaptive pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. AF Suppression™ algorithm (dual-chamber pulse generators, CRT-Ps) stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-chamber pacing (dual-chamber pulse generators, CRT-Ps), though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. 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. Single-chamber atrial pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction. For specific contraindications associated with individual modes, refer to the programmer's on-screen help.

Leadless Pacemaker Potential 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.

Traditional Pacemaker Potential Adverse Events: The following are potential complications associated with the use of any pacing system: air embolism; body rejection phenomena; cardiac tamponade or perforation; hematoma, bleeding hematoma, seroma; formation of fibrotic tissue, local tissue reaction; inability to interrogate or program due to programmer or device malfunction; infection; erosion; interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic; lead malfunction due to conductor fracture or insulation degradation; loss of capture or sensing due to lead dislodgement or reaction at the electrode/tissue interface; loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to insulation); loss of normal device function due to battery failure or component malfunction; pacemaker migration or pocket erosion; pectoral muscle or diaphragmatic stimulation; phrenic nerve stimulation; pneumothorax/hemothorax; device migration and pocket erosion; endocarditis; excessive bleeding; induced atrial or ventricular arrhythmias; myocardial irritability; pericardial effusion; pericardial rub; pulmonary edema; rise in threshold and exit block; valve damage; cardiac/coronary sinus dissection (CRT-Ps only); cardiac/coronary sinus perforation (CRT-Ps only); coronary sinus or cardiac vein thrombosis (CRT-Ps only); death.

Indicates a trademark of the Abbott group of companies.

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