The FDA earlier this week issued a letter highlighting certain complications associated with leadless pacemaker implantation, including with Medtronic’s (NYSE:MDT) Micra platform.
In the letter, the FDA noted that the overall risk of cardiac perforation associated with leadless pacemaker implantation appears similar to the risk associated with traditional transvenous pacing systems. Still, premarket clinical studies of Medtronic’s Micra have suggested that major complications related to cardiac perforation appeared more severe for patients with a leadless pacemaker compared to those with a transvenous one.
Real-world data suggest that cardiac perforations associated with Micra pacemakers are more likely to be associated with serious complications, including cardiac tamponade or death, when compared to traditional pacemakers, FDA said.
“Since the Micra Transcatheter Pacing System (TPS) received premarket approval in 2016, Medtronic has worked with the FDA to continuously monitor the safety and effectiveness of this novel leadless pacing device,” Medtronic wrote in a statement. “The FDA’s letter, published today, is consistent with the training and education programs and Instructions for Use (IFUs) we’ve previously provided to physicians, and we support the important reminders provided in the letter. ”
Medtronic said it encourages and supports studies evaluating its devices, noting that the Micra TPS is “well-studied” with more than 17,000 Micra TPS patients in more than 200 independent publications.
The company added that multiple studies have demonstrated a high rate of implant success (exceeding 99%) with the leadless MicraTPS, with rates of major complications remaining stable over time, as confirmed by FDA. Medtronic also said the platform has been shown to reduce the risk of major complications compared to traditional pacemakers through 12 months.
“Rates of major complications have remained stable over time, and we will continue to partner with FDA to ensure that physicians can continue to make informed decisions regarding patient care,” a Medtronic spokesperson said.