Not only is the pacemaker the smallest, it does not require wired leads to provide an electrical connection between the pulse-generating device and the heart. The device is very small, resembling the size of a pill (24 millimetres in length, making it just one-tenth the size of other pacemakers.) The size allows the pacemaker to be implanted directly into the heart, and this positioning means that wires are not required. The absence of wires is not only of practical benefit, it also reduces the chance of infection.
Another advantage is with the battery life. The new pacemaker can last for around 10 years before it needs replacing.
A pacemaker (more technically an “artificial pacemaker”) is a type of medical device that uses electrical impulses, delivered by electrodes contracting the heart muscles, to regulate the beating of the heart.
Approval for the pacemaker has come from the U.S. Food and Drug Administration (FDA). Speaking with QMed, Dr. William Maisel, who is head up the FDA’s Office of Device Evaluation, 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 pacemaker is currently approved for those patients with atrial fibrillation (an abnormal heart rhythm characterized by rapid and irregular beating) or associated arrhythmias (like bradycardia-tachycardia syndrome, which is another form of heart rhythm disorder.)
This followed a clinical trial of 719 patients implanted with the Micra device. Here 98 percent of patients showed adequate heart pacing six months after device implantation. This indicated effectiveness as well as being safe.
A second mini-sized pacemaker is set again regulatory approval. This is St. Jude Medical’s Nanostim device. This will be of a similar size to the Micra device.
