FDA on Wednesday approved the first-ever wireless pacemaker for sale in the United States.
Traditional pacemakers, which are implanted under the skin near the collar bone, use wires—or leads—to connect to the heart through individuals' veins. Those wires can lead to complications if they break or become infected.
To avoid these problems, Medtronic developed a new leadless pacemaker, called the Micra Transcatheter Pacing System, which is implanted directly in the heart's right ventricle.
The one-inch device can be inserted through a vein in the groin that leads to the heart, eliminating the need for surgery for implantation.
Micra's approval was based on data from a clinical trial that found 98 percent of 719 participating patients had maintained stable heart pacing six months after receiving the device.
William Maisel, acting director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health, in a statement 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."
The device is intended to be used for patients with irregular heartbeats, including individuals with:
- Atrial fibrillation; and
- Bradycardia-tachycardia syndrome.
The device is not recommended for individuals who:
- Have implanted devices that could interfere with the pacemaker;
- Have an intolerance to materials that make up the device or to the drug heparin;
- Have veins that cannot accommodate the device's width; and
- Are severely obese.
In addition, Micra is not appropriate for patients who need pacing in the heart's upper chambers because the device paces only the lower chambers, according to John Hummel, a cardiologist and medical professor at Ohio State University who helped conducted the clinical trial.
Hospitals test out the world's smallest pacemaker
Still, Hummel says Micra "represents the threshold of a future of leadless pacemakers," noting that new wireless devices to work in both the upper and lower chambers of the heart are under development (Shaji, Reuters, 4/6; Whalen/Beckerman, Wall Street Journal, 4/6; Peck, MedPage Today, 4/6; AP/Washington Times, 4/6).
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