by
Gus Iversen, Editor in Chief | May 19, 2015
The Micra miniature leadless pacemaker from Medtronic is living up to the hype according to the early results of the first human trials. Findings unveiled at Heart Rhythm 2015 illustrate the transcatheter pacing system (TPS) can be safely and effectively applied in patients with a slow heart rhythm.
“The results of this study are very promising and we have seen firsthand how the device size and minimally invasive procedure truly can improve the quality of life for patients,” said lead author, Dr. Philippe Ritter from the Hôpital Haut-Lévêque in France, in a statement.
With a size roughly 93 percent smaller than other permanent cardiac pacing systems that utilize a lead or require a chest pocket, the Micra system has dimensions similar to that of a vitamin capsule. It is implanted directly into the right ventricle of the heart using protractible nitinol tines, by way of the femoral vein.
The international study enrolled 140 patients from 23 countries, and the interim analysis is based on three-month follow-up for the first 60 patients. By looking at adverse effects and electrical variables among patients, the researchers may have reason to be optimistic.
There were no procedural-related deaths, and less than six percent of patients experienced serious adverse events, (which a statement from the Heart Rhythm Society says is comparable to traditional systems).
“The new miniaturized pacemaker not only eliminates many of the traditional complications associated with conventional transvenous pacing, but it also has the potential to advance patient care and set a new standard for single chamber pacemakers," continued Ritter.
Implant time took an average of 37 minutes and the systems are anticipated to have a longevity of roughly 10 years.
While the system is not yet FDA approved, it did receive
CE Mark in Europe.
EDIT: An earlier version of this story incorrectly stated that the rate of adverse events with the Micra system was comparable to other TPS systems when it is actually comparable to traditional systems.
