Meet Micra Transcatheter Pacing System (TPS), the world’s smallest pacemaker that is nearly as big as a large vitamin tablet. Developed by Dublin-based medical technology company Medtronic, the tiny device recently underwent clinical trials, involving 744 patients from as many as 19 countries. According to the developers, the Micra pacemaker was successfully implanted in around 99.2-percent of the patients, with minimal complications.
The outcomes of the clinical trials were presented at the recent American Heart Association Scientific Sessions, and also appeared in the New England Journal of Medicine. Extending over a period of six months, the trials showed very low complication rates, with nearly 96-percent of the patients experiencing no major issues from the pacemaker. This is significantly lower than the 51-percent complication rate associated with commonly-available pacing systems. Speaking about the breakthrough, Dwight Reynolds, the chief of the Cardiovascular Department at the University of Oklahoma Health Services Center and the trials’ principal investigator, said:
We are extremely pleased with the remarkably successful implant rates and safety profile of the Micra pacemaker, including the absence of device dislodgement… The Micra TPS not only met its trial endpoints, but also provided a significant reduction in healthcare utilization due to fewer major complications compared to conventional pacing systems, which is particularly important in an era of value-based healthcare.
Measuring around one-tenth the size of conventional pacemakers, the Micra TPS is the most minimally invasive pacing technology available at present. Unlike current pacemaker implantation procedures which include complicated surgical incision and the creation of pockets under the skin, the new contraption can be directly embedded into the heart with the help of a catheter. Furthermore, it does not rely on inconvenient wires or ‘leads’, and instead uses specially-designed flexible tines that are attached to the interior of the right ventricle. Mikhael El Chami, a scientist at the Emory University and a member of the research team, explained:
By not creating a pocket and implanting a rigid device directly below the skin, it eliminates another potential source of complications and any visible sign of the device.
Programmed to send electrical impulses to the heart for proper pumping of blood, the tings can be easily disengaged and re-positioned, without inflicting any kind of trauma. The absence of wires also prevents other cardiac complications, such as vein injury and infection. During the course of the trials, the major complications, which did arise in patients with the Micra pacemaker, consisted mainly of cardiac injuries (around 1.6-percent), groin-related issues (about 0.7-percent) and pacing problems (0.3-percent). In comparison to traditional pacing devices, the Micra TPS caused zero systemic infections and dislodgements in patients. Michael S. Lloyd, from the Emory University, added:
We were pleased to participate in this important trial, as this will likely be the way pacemakers are implanted in the future. The outstanding results are very encouraging and will allow us to continue to offer this novel device as a safe alternative to our patients.
The company is currently awaiting approval in the United States for commercial use.