A major medical milestone has been achieved with the FDA’s approval of the Aveir DR Dual-Chamber Leadless Pacemaker by Abbott. This innovative device is designed to treat patients with abnormal or slow heart rhythms (cardiac arrhythmia) and is the first of its kind to provide leadless pacing for both chambers of the heart.

What Makes the Aveir DR Pacemaker Unique?

Traditionally, pacemakers have used wires (leads) to connect to the heart. However, these wires can sometimes cause complications. Leadless pacemakers, like Aveir DR, eliminate the need for wires, reducing risks and making the procedure less invasive.

The Aveir DR system uses two tiny pacemakers:

• Aveir AR for the right atrium.
• Aveir VR for the right ventricle (already FDA-approved).

These pacemakers communicate wirelessly using Abbott’s advanced i2i technology, which is powered by the patient’s own blood flow. This innovative design uses less battery compared to traditional communication methods like Bluetooth or radiofrequency.

Who Can Benefit from This Device?

Dual-chamber pacing is recommended for patients with conditions such as:

• Sick sinus syndrome (problems with the heart’s natural pacemaker).
• Adams-Stokes syndrome (fainting due to a slow heart rate).
• AV block (signal blockage between the heart’s chambers).
• Bilateral bundle-branch block (delayed electrical impulses in the heart).

How Does It Work?

Both Aveir pacemakers are smaller than a AAA battery and are implanted directly inside the heart through a minimally invasive procedure. They attach to the heart wall with a tiny screw-like mechanism, making removal easier if needed in the future.

Impressive Results from Clinical Studies

The device’s approval was based on the Aveir DR i2i study, which showed:

• A 98.3% success rate in implanting the device.
• Over 97% of patients had successful heart synchronization between the atrium and ventricle after three months.
• 90.3% of patients had no serious device- or procedure-related complications after 90 days.

Some minor complications reported included atrial fibrillation, lead dislodgement during the procedure, and rare cardiac injuries.

Why Is This a Big Deal?

Until now, leadless pacemakers were limited to single-chamber pacing due to the difficulty of wireless synchronization. The Aveir DR system solves this challenge, offering dual-chamber pacing with greater safety and efficiency.

What Experts Are Saying

Director of cardiac arrhythmia services at Mount Sinai, called the approval a technological achievement that changes how doctors treat heart rhythm problems. Abbott’s senior VP, highlighted how the device solves a long-standing engineering challenge in cardiac care.

The Future of Heart Care

The Aveir DR Dual-Chamber Leadless Pacemaker represents a leap forward in treating abnormal heart rhythms. Its cutting-edge technology offers hope for millions of patients, making heart care safer, simpler, and more effective.

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