Abbott’s AVEIR Dual Chamber Leadless Pacemaker System Receives the US FDA’s Approval for Abnormal or Slow Heart Rhythms
Shots:
- The US FDA has approved the AVEIR dual chamber (DR) leadless pacemaker system for the treatment of patients with abnormal or slow heart rhythms
- The approval was based on the AVEIR DR i2i Investigational Device Exemption (IDE) study evaluating the dual-chamber leadless pacemaker system which showed that the AVEIR DR system met its three prespecified 1EPs for safety and efficacy
- The results also showed a 98.3% implant success rate for physicians through 3mos. post-implant and ≥97% had successful atrioventricular synchrony so that the upper and lower chamber were beating normally, despite different types of underlying slow heart rhythms. The results were published in the NEJM
Ref: PR Newswire | Image: Abbott
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
