After 12 months of follow-up, 96 percent of patients who received the Micra transcatheter pacing system (Medtronic) had no major complications.
Patients implanted with the Micra had a 48 percent reduction in the risk of major complications compared with conventional systems, according to a Medtronic news release. The company also said the risk was lower in all subgroup analyses based on age, sex or comorbidity.
The results were presented in a late-breaking session at the European Society of Cardiology (ESC) Congress in Rome on Aug. 28.
The FDA approved the Micra system in April, making it the first commercially available leadless intracardiac transcatheter pacing system in the U.S. The approval was based on a prespecified interim analysis that found 96 percent of patients did not have system-related or procedure-related major complications at six months. The Micra was successfully implanted in 99.2 percent of patients.
The findings of that analysis were published in the New England Journal of Medicine in November 2015 and simultaneously presented at the American Heart Association Scientific Sessions.
At the ESC Congress, researchers revealed updated data from that ongoing study. After 12 months, the Micra was associated with a 47 percent reduction in the risk of hospitalization and an 82 percent decrease is the risk of system revisions compared with conventional pacing systems.
Medtronic also said that the Micra had a projected average longevity of more than 12 years based on an analysis of 644 patients. The Micra is a single-chamber ventricular pacemaker that is comparable in size to a large vitamin.
“The Micra TPS has consistently demonstrated strong effectiveness and safety benefits in patients with diverse comorbidities,” lead researcher Philippe Ritter, MD, a cardiologist at University Hospital of Bordeaux in France, said in a news release. “All pre-specified safety and efficacy objectives from the trial were met, with consistent findings from early performance, six-month, and 12-month data.”