FDA approves first leadless dual-chamber pacing system; A breakthrough in therapy of bradycardia

Abstract

More than 700,000 pacemakers (PMs) are implanted worldwide each year, with more than 250,000 deployed in the United States. Leadless cardiac pacemakers (LPCs) are an alternative to conventional pacemakers because they do not require permanent transvenous leads while alleviating bradyarrhythmias. An innovation in the field of pacing systems called ‘dual chamber pacing system’ has received US Food and Drug Administration (FDA) approval which is a safe, non-invasive, and efficacious procedure as documented by a landmark clinical study. It succeeded in its pre-established safety and performance goals, with definite procedural success, atrial pacing and reliable atrioventricular (AV) synchrony. Despite its hailing success, the system continues to undergo transformation and development, and requires further longitudinal data to reaffirm its safety and efficacy.