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Cardio Catch-Up: Abbott Plans To Expand Pacemaker Market With Leadless Aveir DR

 
• By Reed Miller

The FDA approved Abbott’s Aveir DR dual-chamber leadless pacemaker system, which will complement Abbott’s Aveir VR technology and help Abbott compete directly with Medtronic in the growing leadless cardiac rhythm management device market.

Aveir
• Source: Abbott

The US Food and Drug Administration approvedAbbott’s Aveir dual chamber (DR) leadless pacemaker system.

About 80% of people who need a pacemaker to treat bradycardia or another abnormal heart rhythm will need dual-chamber pacing. “The approval [of Aveir DR] significantly increases access to...

Aveir DR i2i Results

The FDA approved the Aveir DR based on results from Aveir DR i2i, a 300-patient single-group study.

The trial met its primary safety...

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More from Policy & Regulation

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A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.