The U.S. Food and Drug Administration approved the first leadless pacemaker on Wednesday.
The device comes from Medtronic of Mounds View, Minn., and is called Micra. The traditional pacemaker is implanted under the skin near the collarbone. Its leads run through a vein directly into the heart's right ventricle. These leads can sometimes malfunction when infections develop in surrounding tissues, which requires surgery to replace the device. Instead of wired leads, Micra uses small prongs to attach directly to the heart, where it delivers electrical pulses to coordinate heart contractions.
To merit the approval, the FDA examined data generated by a clinical trial of more than 719 heart patients given the Micra. Ninety-eight percent of patients had adequate heart pacing six months after the device was implanted. Complications arose in less than seven percent of patients studied.
William Maisel, MD, acting director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said, "As the first leadless pacemaker, Micra offers a new option for patients considering a single chamber pacemaker device, which may help prevent problems associated with the wired leads."
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