Since the Micra Transcatheter Pacing System (TPS) received pre-market approval in 2016, Medtronic has worked with the FDA to continuously monitor the safety and effectiveness of this novel...
Since the Micra Transcatheter Pacing System (TPS) received pre-market approval in 2016, Medtronic has worked with the FDA to continuously monitor the safety and effectiveness of this novel leadless pacing device. 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.
We encourage and support studies that evaluate our devices and are fully committed to understanding how our products perform throughout their lifetime and beyond. The Micra TPS is well studied, with more than 17,000 Micra TPS patients in more than 200 independent publications.
Multiple studies have shown that the leadless Micra TPS has a high rate of implant success (exceeding 99%). As stated in the FDA’s letter, rates of major complications have remained stable over time. Additionally, Micra TPS has been shown to reduce the risk of major complications compared to traditional pacemakers (through 12-months):
Further, several studies have shown that patients receiving the Micra TPS tend to be sicker as demonstrated by more co-morbidities than patients receiving traditional pacemakers (see below).
We will continue to partner with the FDA to ensure that physicians have accurate, clinically-actionable information to make informed decisions regarding patient care.
In addition to the studies mentioned above, Medtronic continuously monitors our Global Complaint Handling (GCH) database to evaluate performance and safety data and provides periodic updates to our Medtronic CRM Product Performance Report (PPR) on the performance of Micra.
In the US, there is an additional opportunity to assess the outcomes of Micra TPS in the Micra Coverage with Evidence Development (CED) Study, which is a continuously enrolling, observational, cohort study evaluating complications, utilization, and outcomes of Micra TPS in the US Medicare fee-for-service population.
The July 2021 publication of the Micra Coverage with Evidence Development (CED) Study showed when compared with transvenous-VVI patients (N=9,662), Micra patients (N=5,746) were more likely to have end stage renal disease (12.0% vs. 2.3%, P<0.0001) and a higher Charlson Comorbidity Index score (5.1 vs. 4.6, P<0.0001).
Medtronic is committed to timely publication and transparency of Micra TPS performance data and in June 2021 added Micra TPS to its Product Performance Report. To date: