The U.S. Food and Drug Administration has approved an injectable pacemaker that doesn’t require wired leads, which often lead to complications.
The one-inch long Medtronic-built device, called the Micra Transcatheter Pacing System, is about a tenth the size of traditional pacemakers—making it the smallest in the world.
It’s intended for patients with atrial fibrillation (an irregular or rapid heart rate) and other dangerous arrhythmias, including bradycardia-tachycardia syndrome. The FDA approved the device in light of a Medtronic clinical trial involving 719 patients who were implanted with the device. After six months, around 98 percent of the patients experienced adequate heart pacing. A small fraction (7 percent) of patients experienced major complications, such as cardiac injuries, device dislocation, and blood clots.