Clinical Data
The Micra TPS is less than one-tenth the size of traditional pacemakers and cosmetically invisible, yet provides the most advanced pacing technology available. It is implanted directly into the heart and does not require the use of wires ("leads") to deliver pacing therapy, thereby reducing potential sources of complications seen with conventional pacing systems. Results from the Micra TPS Global Clinical Trial recently were published in the New England Journal of Medicine and presented during a late-breaking Special Report at the 2015 American Heart Association Scientific Sessions. In the clinical data presentation, the MicraTPS was successfully implanted in nearly all patients (99.2 percent) and exceeded safety and effectiveness endpoints with wide margins. Most patients (96 percent) with the Micra device experienced no major complications; there were no (0) dislodgments, no (0) systemic infections, and very few (0.4 percent) revisions (meaning extraction, repositioning or replacement). Major complications included cardiac injuries (1.6 percent), complications at the groin site (0.7 percent) and pacing issues (0.3 percent).The study included a comparison of Micra TPS safety performance to a pre-defined, historical control group consisting of more than 2,500 patients who received conventional pacing systems. Compared to patients with conventional pacing systems, the patients in the Micra trial were older and had more comorbidities, yet had fewer major complications.