Medtronic plc Announces New Data from the Micra Coverage with Evidence Development Study
August 27, 2021 at 08:00 am EDT
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Medtronic plc announced new data from the Micra Coverage with Evidence Development Study, the large evaluation of leadless pacemakers to date, which showed the Micra Transcatheter Pacing System was associated with a 38% reduction in reinterventions and a 31% reduction in chronic complications at 2-years compared with traditional transvenous pacemakers. The data were presented virtually in a late-breaking trials presentation at the European Society of Cardiology Congress 2021. The Micra CED study is a continuously enrolling, observational, cohort study evaluating claims-based complications, utilization and outcomes of Micra TPS in the U.S. Medicare fee-for-service population. It is the first study to use Centers for Medicare & Medicaid Services administrative claims data to evaluate clinical outcomes of leadless pacing in the real-world setting and compare outcomes to a contemporaneous cohort of patients implanted with transvenous-VVI pacemakers. The CED study used statistical adjustment to account for differences in patient characteristics at baseline. Although Micra patients had more co-morbidities than transvenous VVI patients, the adjusted results showed patients with Micra had significantly fewer reinterventions compared to patients with TV-VVI devices (Micra 3.1% vs. TV-VVI 4.9%; adj. P=0.003) including significantly fewer system revisions, device removals, and upgrades to cardiac resynchronization therapy. Micra TPS patients also had significantly fewer chronic complications at 2-years (Micra 4.6% vs TV-VVI 6.5%; adj. HR 0.69, 95% CI: 0.60-0.81, P<0.0001). Although Micra patients had more comorbidities than transvenous-VVI patients, there was no difference in adjusted all-cause mortality at 2-years compared to the transvenous comparator population (adj. HR 0.97, 95% CI 0.91-1.04, P=0.37). Researchers evaluated 6,219 patients implanted with Micra VR TPS and 10,212 patients implanted with traditional TV-VVI pacemakers; they compared system reinterventions, chronic complications, and all-cause mortality at 2-years after implant. Overall, patients implanted with Micra TPS were sicker (with a greater comorbidity burden) than TV-VVI patients, with higher rates of end stage renal disease (ESRD) (12.0% vs. 2.3%) and renal dysfunction (48.8% vs. 42.1%), and a higher Charlson Comorbidity Index score (5.1 vs. 4.6).
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).