Medtronic (NYSE:MDT) today released one-year results from the post-approval registry study of its Micra leadless transcatheter pacing system, touting a high implant success rate and a low complication rate.
Results from the study are slated to be presented tomorrow at the Heart Rhythm Society’s annual scientific sessions conference in Boston, the Fridley, Minn.-based company said.
Medtronic’s Micra pacemaker is approximately 1/10th the size of a conventional pacemaker, and is designed to be implanted via catheter into the right ventricle to deliver single-chamber pacing. The system features a battery with an estimated 12-year battery lifespan, and is cleared for use with full-body MRI scans. The FDA approved Micra in April 2016.
The post-approval registry study examined data from 1,817 patients across 23 countries compared to a reference dataset of 2,667 patients with transvenous pacemakers.
“Medtronic is committed to providing the most advanced technologies that improve lives of patients around the world. 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,” Medtronic cardiac rhythm and heart failure division chief medical officer Dr. Rob Kowal said in a press release.
New data from the registry study indicated that the Micra system had an implant success rate of 99.1% with a major complication rate of 2.7% through one year. Procedures to implant the device were reported as having a 63% lower risk for major complication compared to traditional pacing systems, Medtronic said, with the risk of major complication trending lower in the post-approval study than in its earlier investigational study.
Medtronic said that data from the study indicated the Micra system was a safe and feasible pacing option for patients with recent cardiac implantable electronic device infections, with 98 of 99 such patients undergoing successful Micra implantation attempts, according to the study.
“The results from the post-approval registry are consistent with the positive outcomes reported with previous Micra TPS data. 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. By eliminating the need for leads and a subcutaneous pocket, miniaturized leadless pacemakers are associated with a low-risk of device-related infection. These new data show that this novel technology may provide a safe option for patients with prior device-related infections,” Dr. Mikhael El-Chami of Atlanta’s Emory University School of Medicine said in a prepared statement.
Earlier this month, Medtronic issued a select recall for specific Covidien Endo GIA staplers over possible missing components, according to a safety field notice from the company.