Abbott Scores FDA Nod For First Dual-Chamber Leadless Pacemaker To Treat Abnormal, Slow Heart Rhythms

The FDA has approved Abbott Laboratories' ABT AVEIR dual chamber (DR) leadless pacemaker system, the world's first dual chamber leadless pacing system to treat abnormal or slow heart rhythms. 

Through Abbott's proprietary i2i communication technology, AVEIR DR devices provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on the person's clinical needs. 

The i2i technology utilizes high-frequency pulses to relay messages via the naturally conductive characteristics of the body's blood between each leadless pacemaker. Each implant communicates beat-to-beat with a paired, co-implanted device to support dual-chamber therapy. 

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Roughly one-tenth the size of a traditional pacemaker, the AVEIR DR leadless pacing system is made up of two devices – the previously-approved AVEIR VR single chamber device, which paces the right ventricle, and the now-approved AVEIR AR single chamber device, which paces the right atrium. 

Unlike traditional pacemakers, leadless devices are implanted directly into the heart through a minimally invasive procedure, eliminating the need for cardiac leads. 

The FDA approval comes on the heels of recent late-breaking clinical data published in The New England Journal of Medicine showing that the AVEIR DR system met its three prespecified primary endpoints for safety and efficacy. 

Results from the AVEIR DR i2i Investigational Device Exemption study through three months post-implant showed a 98.3% implant success rate, and more than 97% of people had a successful atrioventricular synchrony so that the upper and lower chamber was beating normally, despite different types of underlying slow heart rhythms.

Price Action: ABT shares are down 0.06% at $107.15 on the last check Wednesday.