WASHINGTON -- The first leadless pacemaker, a device called Micra Transcatheter Pacing System made by Medtronic, on Wednesday.
The leadless design has been a long anticipated advance in the electrophysiology community since pacemaker leads pose a number of potential problems ranging from simple breakage to serious infections, and lead problems sometimes require device explant.
The Micra device works like other pacemakers to regulate heart rate, but the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart. Wire leads in a traditional single chamber pacemaker run from the pacemaker, implanted under the skin near the collarbone, through a vein into the heart's right ventricle, the FDA noted.
Micra is intended for patients with atrial fibrillation or those who have other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.
The FDA based its approval on a pivotal trial in which 98% of the patients implanted with the device maintained capture threshold for 6 months or longer after implant. Complications occurred in fewer than 7% of participants in the clinical trials; these included prolonged hospitalizations, deep vein thrombosis, pulmonary embolism, heart injury, device dislocation and heart attacks.
Micra is contraindicated for patients who have implanted devices that would interfere with the pacemaker, who are severely obese, or who have an intolerance to materials in the device or to heparin. It is also contraindicated for patients with veins that are unable to accommodate the 7.8-mm introducer sheath or pacemaker implant.