Study results for Micra Transcatheter Pacing System in arrhythmia shows safety benefits of treatment- Medtronic

Medtronic announced new results from the Micra Transcatheter Pacing System (TPS) Global Clinical Trial in arrhythmia treatment. The new follow-up data on patients enrolled in the pre-market Micra TPS Global Clinical Trial underscore the safety benefits of the Micra TPS, with only 3.7 percent of patients (27 of 726; Kaplan-Meier estimate) experiencing a major complication, and no patients (0) experiencing a device dislodgement, at 7.7 months of follow-up. The results showed that at 7.7 months, the risk for major complications with Micra is significantly lower - 52 percent lower - than the risk associated with conventional pacing systems.

In addition, the risk for major complications was lower for the Micra TPS relative to conventional systems across all patient sub-groups, whether measured by age, sex or comorbidity. At 7.7 months, Micra TPS continued to provide low and stable pacing thresholds, yielding projected average longevity for the device of more than 12 years based on device use conditions through six-months on 590 patients. This longevity rate is similar to conventional pacing systems. Data were presented at a late-breaking trial session at CARDIOSTIM / EHRA EUROPACE 2016.

In November 2015, preliminary results from the Medtronic Micra TPS Global Clinical Trial were published in the New England Journal of Medicine. Data showed the Micra TPS was successfully implanted in 99.2 percent of patients and the system met its safety and effectiveness endpoints with wide margins. Data from beyond six months, presented today at Cardiostim 2016, reinforced these results with no dislodgments, and no systemic infections. These low complication rates were achieved despite the inclusion of high-risk patients in the study worldwide, including patients with chronic obstructive pulmonary disease (COPD).