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 disordered or slow heart rhythms.
AVEIR DR devices provide synchronized or coordonnée cardio-pacing between two leadless pacemakers based on the patient's clinical needs, with Abbott's proprietary i 2 i communication technology.
The i 2 i technology consists of high-frequency pulses that communicate messages via the naturally conductive characteristics of the blood between each leadless pacemaker. Each implant communicates beat-to-beat with a paired, co-implanted device to support dual-chamber therapy.
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 new-approved AVEIR AR single chamber device, which paces the right atrium.
Unlike conventional pacemakers, leadless devices are implanted directly into the heart by a minimally invasive procedure that eliminates the need for cardiac leads.
The FDA approval comes on the heels of recent early-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.
The AVEIR DR i 2 i Investigatory Device Exemption study through three months post-implantation 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 heartRhythms.
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