FDA Approves First Leadless Pacemaker
Eliminates need to repair wire lead in typical pacemakers that can malfunction
THURSDAY, April 7, 2016 (HealthDay News) -- The first leadless, wire-free pacemaker to treat heart rhythm disorders has been approved by the U.S. Food and Drug Administration.
Medtronic's Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate in people with heart rhythm disorders, but does not use wired leads to make the electrical connection between the device and the heart. The new inch-long Micra device is implanted directly into the right ventricle chamber of the heart, with no wire lead needed. The Micra pacemaker is meant for patients with atrial fibrillation or those with other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.
The FDA approval is based on a clinical trial of 719 patients who received the Micra device. Six months after implantation, 98 percent of the patients had adequate heart pacing. Complications occurred in less than 7 percent of the study participants and included extended hospital stays, deep vein thrombosis, pulmonary embolism, heart injury, heart attack, and dislocation of the pacemaker, the FDA said.
According to the FDA, Micra should not be used in patients who have other implanted devices that would interfere with the pacemaker, who are severely obese, have an intolerance to materials in the pacemaker or to heparin, or whose veins are too small for the implantation procedure.