FDA approves first leadless pacemaker to treat heart rhythm disorders
April 7, 2016 - 10:29 AM
The U.S. Food and Drug Administration today approved the first
pacemaker that does not require the use of wired leads to provide an
electrical connection between the pulse-generating device and the heart.
While the Micra Transcatheter Pacing System works like other pacemakers
to regulate heart rate, the self-contained, inch-long device is
implanted directly in the right ventricle chamber of the heart.
are surgically implanted medical devices that generate electrical
impulses to treat irregular or stalled heart beats, and nearly 1 million
people worldwide are implanted with pacemakers each year. The leads in a
traditional single chamber pacemaker run from the pacemaker, implanted
under the skin near the collarbone, through a vein directly into the
heart’s right ventricle; the leads deliver electric pulses from the
generator to the right ventricle and help coordinate timing of the
chamber’s contractions. Micra eliminates these leads, which can sometimes malfunction or cause problems when infections develop in the surrounding tissue, requiring a surgical procedure to replace the device.
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,” said William Maisel, M.D.,
M.P.H., acting director of the Office of Device Evaluation at the FDA’s
Center for Devices and Radiological Health. Micra is intended for
patients with a heart arrhythmia called atrial fibrillation or those who
have other dangerous arrhythmias, such as bradycardia-tachycardia
The FDA evaluated data from a clinical trial of
719 patients implanted with the Micra device, which found that 98
percent of patients in the trial had adequate heart pacing (known as
pacing capture threshold) six months after the device was
implanted. Complications occurred in fewer than 7 percent of
participants in the clinical trials and included prolonged
hospitalizations, blood clots in the legs (deep vein thrombosis) and
lungs (pulmonary embolism), heart injury, device dislocation and heart
Micra is contraindicated for patients who have implanted
devices that would interfere with the pacemaker, who are severely
obese, or who have an intolerance to materials in the device or the
blood thinner heparin. It is also contraindicated for patients with
veins that are unable to accommodate the 7.8 millimeter introducer
sheath or pacemaker implant.
The Micra device is manufactured by Medtronic, located in Mounds View, Minnesota.
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