First Dual-Chamber Leadless Pacemaker Approved by FDA

The FDA approved the Aveir DR dual-chamber leadless pacemaker, the first such device to make it to the market, manufacturer Abbott announced.

Approved for the treatment of abnormal or slow heart rhythms, the Aveir DR system comprises two small single-chamber pacemakers: the new Aveir AR pacemaker for the right atrium, and the previously approved Aveir VR for the right ventricle.

Both leadless implants are paired for beat-to-beat, wireless communication via Abbott’s proprietary “i2i technology” that relies on the power generated through a person’s blood. These high-frequency pulses use less battery than inductive, radiofrequency, or Bluetooth communication, according to Abbott.

“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” said Vivek Reddy, MD, of the Mount Sinai Hospital in New York City, in an Abbott press release.

Dual-chamber pacing is indicated for patients exhibiting sick sinus syndrome; chronic, symptomatic second- and third-degree AV block; recurrent Adams-Stokes syndrome; and symptomatic bilateral bundle-branch block when tachyarrhythmia and other causes have been ruled out.

Both Aveir pacemakers are smaller than a AAA battery and implanted percutaneously. To facilitate future device removal, the device is attached to the heart’s interior surface via a helical screw-in mechanism.

FDA approval for the Aveir DR was based on the Aveir DR i2i study that showed 90.2% of patients meeting the device’s primary endpoint of adequate atrial capture threshold and sensing amplitude at 3 months. The implant success rate was 98.3%, and more than 97% of people had a successful atrioventricular synchrony at 3 months.

As for safety, device recipients showed 90.3% freedom from device- or procedure-related serious adverse events at 90 days. Complications included atrial fibrillation, serious cardiac injury events, and intraprocedural dislodgements of a leadless pacemaker.

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