A pacemaker, also called a cardiac pacing device, is a small apparatus that’s placed (implanted) in the chest to help control the heartbeat by sending electrical pulses. It keeps the heart beating regularly and prevents it from beating too slowly. However, pacemaker implantation involves a complicated surgical procedure.
In 2006, Medtronic made history by being the first company to obtain FDA approval for its Micra pacemaker. Unlike traditional pacemakers, Micra pacemakers offer a minimally invasive approach as they do not require an incision in the chest to implant the device or cardiac leads to deliver therapy. The leadless device is implanted through a vein in the groin using a simple venous catheterization, leaving no bump under the skin and no chest scar.
The system is implanted without additional devices in the body, unlike standard pacemakers, which also require the placement of electrodes that connect the heart chambers to the pacemaker. Additionally, Micra is entirely self-contained within the heart, eliminating potential medical risks associated with chest incisions and wires running through a conventional pacemaker into the heart.
Touted as the smallest of its kind, Micra is a tiny 2.5 cm capsule, 93% smaller than a regular pacemaker. It represents a major innovative technological leap and is the perfect example of how medical device manufacturers continue to push the boundaries of what’s possible.
The technology is currently intended for patients who, for technical or medical reasons, cannot undergo pacemaker implantation with electrodes (such as patients with venous obstruction) and is also suitable for patients with a high risk of infection from the implantation of a traditional pacemaker, without which they would be left with no medical recourse, putting them at increased risk of significant complications.
Clinical studies published in recent years, which included thousands of patients who underwent a Micra implantation procedure, showed that for the vast majority of patients, the rate of infections and complications was significantly lower compared to standard pacemaker transplants (a reduction of about 60% in the rate of complications).
Micra has been adopted by top medical centers, including Sheba, which Medtronic has recently authorized as a global Micra pacemaker training center for arrhythmia experts. Seven doctors from hospitals across Israel participated in Sheba’s first training course, led by Prof. Eyal Nof, Director of the Invasive Electrophysiology Service at Sheba.
“As a medical center ranked among the world’s best, we have made it our mission to lead in the education and training of medical teams,” said Prof. Roy Beinart, Director of Sheba’s Davidai Arrhythmia Center. “This project, the result of a collaboration with Medtronic, is part of that commitment. We will continue to provide the best possible care to our patients, using leading technologies such as Micra and other innovations.”