FDA Approves First Leadless Pacemaker

FDA Approves First Leadless Pacemaker
FDA Approves First Leadless Pacemaker

The Food and Drug Administration (FDA) has approved the Micra Transcatheter Pacing System (Medtronic), the first pacemaker that does not require wired leads for an electrical connection between the device and the heart. It is indicated for patients with atrial fibrillation or those with other dangerous arrhythmias such as bradycardia-tachycardia syndrome. 

Typically, the leads in a traditional single chamber pacemaker run from the pacemaker that is implanted under the skin by the collarbone, through a vein into the right ventricle. These leads can sometime malfunction or cause problems when infections arise in the surrounding tissue. The 1-inch Micra Transcatheter Pacing System, however, is self-contained and is implanted directly into the right ventricle.

RELATED: Leadless Cardiac Pacemaker Deemed Safe, Effective

The FDA approval was based on data from a clinical trial (n=719) of patients implanted with the Micra device. In the study, 98% of patients had achieved pacing capture threshold 6 months after the device implant. Less than 7% of patients experienced complications, which included prolonged hospitalizations, deep vein thrombosis, pulmonary embolism, heart injury, device dislocation, and heart attacks. 

The Micra Transcatheter Pacing System is not intended for patients who have existing implanted devices that would interfere with the pacemaker, who are severely obese, or who are intolerant to materials in the device or heparin. It is also not intended for patients with veins that cannot accommodate the 7.8mm introducer sheath or pacemaker implant.

For more information call (800) 328-0810 or visit Medtronic.com.

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