Data Reinforce Reduced Complications with Medtronic Micra Transcatheter Pacing System Over Traditional Pacemakers in Real-World Use
Results Presented at Heart Rhythm 2018 Also Show Leadless Pacemaker is Safe Option for Patients with Past Device Infection
DUBLIN and BOSTON, Medtronic plc today announced that results through 12-months from the Post-Approval Registry (PAR) for the Medtronic Micra(TM) Transcatheter Pacing System (TPS), reinforcing the high implant success rate and low complication rate seen since its U.S. approval two years ago, will be presented on Thursday, May 10 at Heart Rhythm 2018, the Heart Rhythm Society's 39th Annual Scientific Sessions in Boston.
The smallest pacemaker in the world, Micra TPS is the only leadless pacemaker approved in the U.S. New data from the PAR study showed Micra TPS in clinical practice had an implant success rate of 99.1 percent. The PAR study also showed a low major complication rate (2.7 percent) through 12 months post-implant (95 percent CI: 2.0 percent - 3.6 percent), with a 63 percent lower risk for major complication (P<0.001) compared to traditional pacing systems. Additionally, the risk for major complication trended lower in the Micra Post-Approval Registry than in the investigational study (HR: 0.71, 95 percent CI: 0.44-1.1; P=0.160).
"The results from the post-approval registry are consistent with the positive outcomes reported with previous Micra TPS data," said Mikhael El-Chami, M.D., director of electrophysiology at Emory Midtown and associate professor of medicine at Emory University School of Medicine in Atlanta. "The high implant success and low major complication rates in a real-world patient population with new Micra implanters reinforce the safety and performance of the Micra TPS."
PAR data also show that Micra TPS is a safe and feasible pacing option for patients with a recent cardiac implantable electronic device (CIED) infection. Among patients in the Micra PAR who previously had a traditional pacemaker explanted due to infection, 98 of 99 patients underwent a successful Micra implant attempt (99 percent implant success rate). No patients who received a Micra device experienced infections that required removal.
"By eliminating the need for leads and a subcutaneous pocket, miniaturized leadless pacemakers are associated with a low-risk of device-related infection," said Dr. El-Chami. "These new data show that this novel technology may provide a safe option for patients with prior device-related infections."
The global Micra PAR is a prospective single-arm observational study designed to assess the safety and effectiveness of the Micra TPS in the post-approval setting. PAR data presented at Heart Rhythm 2018 were from an analysis of 1,817 patients at 179 centers across 23 countries worldwide, which assessed system or procedure-related major complications through 12 months following implant. These rates were then compared to the major complication rates of the Micra IDE and to a reference dataset of 2,667 patients implanted with a transvenous pacemaker.
"Medtronic is committed to providing the most advanced technologies that improve lives of patients around the world," said Rob Kowal, M.D., Ph.D., vice president and chief medical officer of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. "The leadless Micra pacemaker is an excellent example of one of those technologies, and now we know that it performs well for patients in a real world setting as well as in a clinical trial."