The Micra leadless pacemaker made by Medtronic (NYSE:MDT) showed a high implant success rate and low rates of major complications in a post-approval registry study released today at the annual Hearth Rhythm Society conference in Chicago.
The study followed 795 patients implanted with the Micra device, which won FDA approval in April 2016. The safety endpoint was system- or procedure-related major complications at 30 days, compared with the major complication rate from Medtronic’s 726-patient investigational trial.
Micra was successfully implanted in 99.6% of patients. The 30-day major complications rate was 1.51%, compared with 2.89% for the investigational study. The rates of cardiac effusion/perforation, device dislodgement and sepsis were each 0.13%.
“Performance of the Micra transcatheter pacemaker in a real-world setting demonstrates a high 99.6% implant success rate and low (1.51%) major complication rate at 30 days. In particular, the rates of pericardial effusion, device dislodgement and infection were low, reinforcing the positive results seen in the investigational trial,” according to the study.
Medtronic said that more than 20% of patients in the registry study had at least 1 condition preventing them from treatment with a conventional transvenous pacer. Some 87% of physicians in the study had never implanted Micra before, the company said.
“It is encouraging to see these strong outcomes with such a novel technology in the hands of new implanting physicians,” lead author Dr. Mikhael El-Chami said in prepared remarks. “The high implant success and low major complication rates in a real-world patient population reinforce the positive results seen in the investigational Micra clinical trial.”
“These positive early data in the post-market setting reinforce the careful attention that went into the design of the Micra TPS and the rigorous training program we have put in place for new implanting physicians of the device,” added cardiac rhythm & heart failure medical director Dr. Rob Kowal. “We look forward to sharing additional outcomes as we gain even more experience through this post-market registry.”