You learn something new every day, as the saying goes.
So here’s a very big takeaway for today: You are now living in a new era for pacemakers.
The AVEIR DR system, the first dual chamber leadless pacemaker approved by the U.S. Food and Drug Administration, has arrived. And that is major news for anyone managing an abnormal or slow heartbeat.
Its groundbreaking design signals “a complete revolution in how we think about and how we implant pacemakers,” said Dr. Cyrus Hadadi, Associate Director of Cardiac Arrhythmia Research at Medstar Heart and Vascular Institute.
With help from Hadadi, let’s go over three things you need to know about the AVEIR DR dual chamber leadless pacemaker system.
1. The AVEIR DR System Paces Two Chambers of the Heart for AV Synchrony
“We truly have a revolution in that you have two modules that synchronize the top and the bottom of the heart,” Hadadi said. “And that’s never been done before with a leadless pacemaker. It’s an ‘invention-of-the-internet’-type of moment for pacemaking.”
Let’s zoom out for a moment and talk about the difference between leadless and traditional pacemakers. A traditional pacemaker runs wires called “leads” down through the chest and into the heart from a pulse generator implanted near the collarbone.
Leadless pacemakers such as our AVEIR VR system, however, are self-contained. They house the battery and all other components in a package that’s smaller than a triple-A battery. They can be implanted directly in the right ventricle of the heart and pace from there. No wires necessary.
The AVEIR DR system represents another upgrade. Now, physicians can implant a second leadless pacemaker in the atrium and have it communicate — again, without any wires — with the pacemaker in the ventricle.
With leadless pacemakers in two chambers of the heart, patients can achieve what’s called AV synchrony: pacing the atrium and the ventricle at the same time so that the beat of the heart is more like parts of a song coming into harmony.
2. AVEIR DR is Implanted in a Minimally Invasive Procedure, With No ‘Bump’
The old way of doing things involved making a “pocket” for the pacemaker in the chest (and, as we mentioned, running the leads down through blood vessels and into the heart). For many patients, the insertion of a pacemaker creates a visible bump on the chest.
With the AVEIR DR system, “there’s no incision on your chest, there’s no bump,” Hadadi said. Instead, in a minimally invasive procedure, doctors make a small incision near the femoral vein and AVEIR is implanted from there.
If anything, patient safety gets a bump in a few specific areas.
Consider that the “pocket” incision can become infected, especially if you need it reopened to replace the pacemaker. Meanwhile, the leads on a traditional pacemaker come with potential complications of their own. By doing away with leads altogether, the AVEIR DR system eliminates the risks associated with lead fractures, insulation breaches on the leads, and lead-related venous thrombosis and obstruction.
Without leads to worry about, you don’t have to restrict your upper-body movement right after your procedure, as you would if you’d received a traditional pacemaker. So raise your hand, swing a golf club, twist and shout: Such is life when you have a leadless pacemaker system.
3. The AVEIR DR System Represents a Big Leap in Health Tech
“The way that we implant a traditional pacemaker is, in many ways, fundamentally unchanged from 1959,” Hadadi said. “You’re screwing a long wire into the heart and connecting it to a battery.”
It’s safe to call the AVEIR DR system a fundamental change. The atrial and ventricular AVEIR units can send communications to one other once every cardiac cycle — once every heartbeat — to stay coordinated. If the heart needs a boost to beat faster, the system senses it and can adjust in fractions of a second.
Meanwhile, if and when the time comes to replace your pacemaker, the AVEIR DR system provides another innovative benefit. Each unit can be retrieved in a minimally invasive procedure, making way for a new AVEIR to take its place.
And, again, there are no chest scars to show for it. “Patients love showing off to their friends: ‘Hey, find my pacemaker,’ ” Hadadi said.
Call it a game-changer, a sea change — whatever term you prefer. The bottom line is that the AVEIR DR system has opened up a new world of possibilities for living a healthy life.
IMPORTANT SAFETY INFORMATION
AVEIR™ DR
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 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.
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:
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.
MAT-2306873 v1.0 | Item is approved for US Use
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