FDA Approves First Leadless Pacemaker

The U.S. Food and Drug Administration (FDA) approved the Micra Transcatheter Pacing System, the first leadless pacemaker to treat cardiac arrhythmias. The Micra device is intended for patients with atrial fibrillation or dangerous arrhythmias, such as bradycardia-tachycardia syndrome.

According to the FDA, the device should not be used in patients with “implanted devices that would interfere with the pacemaker, who are severely obese, or who have an intolerance to materials in the device or the blood thinner heparin.”

Read the FDA announcement.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Anticoagulants, Atrial Fibrillation, Bradycardia, Heparin, Pacemaker, Artificial, Sick Sinus Syndrome, Tachycardia, United States Food and Drug Administration

< Back to Listings