Dublin-based Medtronic revealed encouraging results from a study completed on its Micra Transcatheter Pacing System (TPS), which showed a 99.6 percent implant success rate and low chances of major complications occurring.
The results were presented May 11 at this year’s Heart Rhythm Society conference in Chicago. They were also published in Heart Rhythm.
"It is encouraging to see these strong outcomes with such a novel technology in the hands of new implanting physicians," said Mikhael El-Chami, MD, director of electrophysiology at Emory Midtown and an associate professor of medicine at Emory University School of Medicine in Atlanta, in a statement. "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."
The prospective single-arm observational study was designed to assess the safety and effectiveness of Medtronic’s TPS. The data presented at the conference reflected an interim analysis of almost 800 patients treated by 149 physicians at 97 centers across 20 counties, according to the study. Investigators followed patients after they received the TPS for 30 days.
Results showed that 20 percent of patients had at least one condition that could not be treated with a transvenous pacemaker. Almost 87 percent of the doctors in the analysis were unfamiliar with Micra. Additionally, major complications were low. Only 1.51 percent of patients experienced a major complication at 30 days post-implant.
"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," said Rob Kowal, MD, PhD, vice president and medical director of the Cardiac Rhythm and Heart Failure Division at Medtronic, in a statement. "We look forward to sharing additional outcomes as we gain even more experience through this post-market registry."