The AP (4/6) reports that the Food and Drug Administration “has approved the first pacemaker to do away with electrical wires that have long been a shortcoming of internal heart devices.” The device, called the Micra Transcatheter Pacing System, is made by Medtronic PLC and is “implanted directly into the heart’s lower-right chamber.”
The Wall Street Journal (4/7, ) reports that the device is intended for patients who have irregular heartbeats, including atrial fibrillation or bradycardia-tachycardia syndrome, according to the FDA.

New wireless pacemaker. Medtronic photo.

Wireless pacemaker sits in the right ventricle. No wires needed. Internet photo. 4/16/

Blogfinger Medical Commentary:   Paul Goldfinger, MD, FACC.   Blogfinger Off-shore School of Medicine, Ocean Grove, NJ

When complications occur with permanent pacemakers, often the issue is with the wires which can get infected, perforate the heart or cause clotting. Pacemakers sit in a “pocket” under the skin beneath the collar bone. That pocket is created surgically, and problems can develop such as bleeding or infection.

The generator connects to the interior of the heart with special wires, usually one or two per patient.   Years ago I ran into cases where the wire broke, became displaced,  or got infected. Sometimes a wire had to be removed, but that was a tricky procedure, and there were specialists who became known for their ability to extract wires which had become scarred into place at the tips.

Occasionally the original placement of the wire would be problematic, and I saw cases that took hours before the surgeon got the wires correctly in place. In recent years, the placement of pacemakers became the domain of cardiologists with special training, i.e. electrophysiologists.

Here is a link to our recent article about the  history of permanent pacemakers

http://blogfinger.net/2016/02/14/history-of-permanent-cardiac-pacemakers-by-a-cardiologist-whose-career-paralleled-the-evolution-of-that-technology/

The main advantages of wireless pacemakers are that surgery and wires are not needed.

Last November, a study of 725 patients was published in The New England Journal of Medicine describing a new advance: a one inch wireless pacemaker.    Such devices had already been approved in Europe for a year, but only now did the FDA approve it for use in the US.  There are two companies that make the new device: Medtronic and St. Jude—both American companies. Medtronic called its version “The Micra.”  Also Boston Scientific has one on the launching pad.

In 99% of the study cases, the new pacemaker was placed successfully, and with half the complications of the usual units. These new devices are about 1 inch long and are placed by inserting a needle into a groin vein eliminating the necessity of the surgical approach.  Prongs attach the device to the inner lining of the right ventricle. There are no wires.  This is the future of pacemakers, and this device is just the first.

However, there are some issues:

1. Currently only 15-25% of pacemaker patients would be candidates.

2. The battery is supposed to last for 10 years, but there are no long term trials.

3. Techniques to remove a wireless unit are currently being developed.

4. Anyone who needs a dual chamber pacemaker would have to await further developments

5. These new devices are much more expensive than the current ones which work just fine most of the time.