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):

• by 48% as demonstrated in the global Micra Investigational Device Exemption (IDE) Trial
• by 63% in the global Micra Post Approval Registry that included a diverse, real-world patient population where 24% of patients were referred for Micra TPS due to a clinical condition that prevented them from receiving a traditional pacemaker.

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.

Additional Background

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).

• Unadjusted and adjusted device-related complications including dislodgement, infection and pocket complications were significantly lower in the Micra patients compared with the transvenous-VVI patients (unadjusted, 1.4% vs. 2.6%, P<0.001; adjusted, 1.4% vs. 2.5%, P<0.001).
• The unadjusted acute complication rate was higher in Micra relative to transvenous-VVI patients (8.4% vs 7.3%, P=0.019), however there was no significant difference in overall acute complication rates following adjustment for patient characteristics (7.7% vs 7.4%, P=0.49).
• Pericardial effusion and/or perforation within 30 days was significantly higher among Micra patients compared with transvenous-VVI patients (0.8% vs. 0.4%, p=0.004), but remained consistent with or below the rate of perforation observed in other studies.
• Patients implanted with Micra had a lower rate of 2-year complications compared with patients implanted with transvenous-VVI (unadjusted HR 0.75; 95% CI 0.65–0.87, P= 0.0001; adjusted HR 0.69; 95% CI 0.60–0.81, P< 0.0001); representing a 31% reduction on an adjusted basis.
• Both the unadjusted and adjusted overall reintervention rates were significantly lower in the Micra patients compared with the transvenous VVI patients (unadjusted 3.0% vs. 4.8%, P= 0.006; adjusted 3.1% vs. 4.9%, P = 0.003). System revisions, removals, and upgrades to CRT were significantly lower in the Micra patients compared with the transvenous VVI patients.
• Lastly, the adjusted 2-year all-cause mortality rate was not significantly different between Micra and transvenous-VVI patients (cumulative rate 31.4% vs.32.5%; HR 0.97; 95% CI 0.91–1.04).

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:

• There have been 45 Medtronic-sponsored peer reviewed manuscripts published on Micra TPS data, including primary data published in The New England Journal of Medicine in 2016.
• Data from 61 abstracts have been presented at multiple conferences including 10 prominent late breaking or featured clinical trial presentations at major venues, including the American Heart Association Scientific Sessions, Heart Rhythm, and European Society of Cardiology Congress.
• The medical community has generated more than 200 independent, peer-reviewed publications representing experiences with Micra TPS.