The first pacemaker to treat irregular heartbeat without the need for wires between the device and the heart has been approved by the U.S. Food and Drug Administration.
The Micra Transcatheter Pacing System is implanted in the heart’s right ventricle, the FDA said in a news release. In traditional pacemakers, wired leads may malfunction and require the device to be replaced.
The device was evaluated in clinical studies involving 719 people. About 98 percent of people given the device had “adequate heart pacing” six months after surgical implantation, the FDA said. Complications, which affected fewer than 7 percent of trial participants, included extended hospitalization, blood clots in the legs or lungs, heart injury, device dislocation and heart attack.
The device shouldn’t be implanted in severely obese people, or in people who may be intolerant to its components or to the blood-thinning drug heparin, the agency said.
The device is manufactured by Medtronic, based in Mounds View, Minn.
The FDA has more about this approval.
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