Data Presented for Medtronic's Micra TPS Demonstrate Sustained Safety and Efficacy

August 28, 2016—Medtronic plc announced new long-term results from the Micra TPS global clinical trial of the company’s leadless Micra transcatheter pacing system (TPS), which were presented in a late-breaking trial session at the 2016 European Society of Cardiology (ESC) Congress 2016, held August 27–31 in Rome, Italy. 

According to Medtronic, the data presented at ESC showed that the risk for major complications with the Micra TPS remained consistently low, with 96% of patients experiencing no major complications through 12 months of follow-up (95% confidence interval, 94.2%–97.2%; P < .0001). The Micra TPS reduced the risk of major complications by 48% (hazard ratio, 0.52; P = .001) compared to conventional systems, and the risk was lower across all patient subgroups, whether measured by age, sex, or comorbidity (all hazard ratios < 1.0).

The overall reduction in major complications with the Micra TPS was associated with a 47% decrease (P = .017) in risk of hospitalization and an 82% (P < .001) reduction in risk of system revisions (extraction, repositioning, or replacement) compared to conventional pacing systems. These reductions were largely due to the elimination of complications such as pneumothoraces, the absence of Micra dislodgements, and device infections.

In the company’s press release, Philippe Ritter, MD, commented, “The Micra TPS has consistently demonstrated strong effectiveness and safety benefits in patients with diverse comorbidities. All prespecified safety and efficacy objectives from the trial were met, with consistent findings from early performance, 6-month, and 12-month data.” Dr. Ritter is Principal Investigator of the Micra TPS global clinical trial and cardiologist at University Hospital of Bordeaux, France.

The company advised that Micra battery projections continue to perform in line with conventional pacemaker systems. Micra yielded a projected average longevity of > 12 years, based on 644 patients with available 12-month device-use conditions.

In November 2015, Medtronic announced preliminary results showing the Micra TPS was successfully implanted in 99.2% of patients and that the system met its safety and effectiveness endpoints with wide margins in the Micra TPS global clinical trial. The data were presented at the American Heart Association’s Scientific Sessions 2015 in Orlando, Florida, and simultaneously published by the trial’s Principal Investigator Dwight Reynolds, MD, et al in The New England Journal of Medicine (2016;374:533-541). 

The 12-month data presented at ESC 2016 reinforce these results, demonstrating consistent and sustained results from early performance through 12-month follow-up, stated Medtronic.
 
The leadless Micra TPS pacemaker, which is intended for use in patients who need a single-chamber pacemaker, is less than one-tenth the size of traditional pacemakers and is approved for use in both the United States and Europe. The device was awarded European CE Mark approval in April 2015 and US Food and Drug Administration approval in April 2016. 

The Micra TPS is approved for both 1.5 and 3 Tesla full-body MRI scans. The device was designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink Network; remote monitoring of Micra devices is available in Europe and expected to be available in the United States later this year, advised the company.