Medtronic touts 12-month data on Micra leadless pacemaker | ESC 2016

Medtronic (NYSE:MDT) yesterday touted 12-month results for its Micra Leadless pacemaker, released at the annual meeting of the European Society of Cardiology in Rome, showing a vastly lower safety profile than conventional implanted pacemakers.

Fridley, Minn.-based Medtronic said the Micra device, which is designed to be implanted inside the heart via catheter, showed 96% freedom-from-complication rate and cut the risk of major complications by 48%. The risk was lower across subgroups including age, gender and comorbidity, the company said. Risk of hospitalization was lower by 47% and the risk of revision procedures was 82% lower for the Micra cohort, according to the study. The Micra’s battery is projected to last an average of 12 years, based on data from the 644 patients who have had the device for at least 12 months.

The device beat the safety and efficacy endpoints in trial results released in November 2015, showing a 99.2% successful implantation rate and a freedom-from-major-complications rate of 96%, which the company said was 51% lower than the rate for conventional pacemakers.

“The Micra TPS has consistently demonstrated strong effectiveness and safety benefits in patients with diverse comorbidities,” lead investigator Dr. Philippe Ritter, of the University Hospital of Bordeaux, France, said today in prepared remarks. “All pre-specified safety and efficacy objectives from the trial were met, with consistent findings from early performance, 6-month, and 12-month data.”

“The Micra TPS continues to deliver safe and effective pacing, while also providing a less invasive alternative to conventional pacemakers,” added Medtronic cardiac rhythm & heart failure president Dr. John Liddicoat. “The Micra TPS has also shown a significant reduction in healthcare utilization compared to conventional pacemakers, which is promising for clinicians looking to adopt cost-effective therapies to improve patient outcomes.”

Micra won CE Mark approval in the European Union in April 2015 and landed FDA approval a year later.

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