After 7.7 months, patients who were implanted with the Micra Transcatheter Pacing System (TPS) had a statistically significant 52 percent lower risk for major complications compared with those who received a conventional pacing system.
Researchers presented the results in a late-breaking session at the CARDIOSTIM/EHRA EUROPACE 2016 in Nice, France, on June 9.
The FDA approved the Micra TPS on April 6 based on results of a single-arm study at 56 centers in 19 countries. The Micra is the first commercially available intracardiac transcatheter pacing system in the U.S.
The follow-up data showed that only 3.7 percent of patients had a major complication and none had a device dislodgement after 7.7 months. Further, all of patient sub-groups had a lower risk of major complications with the Micra TPS compared with conventional systems. The researchers measured patients based on age, sex and comorbidity, and each of the groups had a lower risk with the Micra TPS.
Medtronic, which manufactures the device, said that the average longevity of the Micra TPS was more than 12 years, based on an analysis of 590 patients who used the device for six months. The company said the longevity was similar to conventional pacing systems.