FDA Approves Medtronic’s Micra Leadless Pacemaker With Large Post-Market Trial Condition
This article was originally published in Clinica
Executive Summary
The US FDA approved Medtronic’s Micra transcatheter leadless single-chamber pacemaker on April 6, beating out St. Jude’s Nanostim to be the first transcatheter leadless pacemaker to earn FDA approval.
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Leadless Pacers Would Only Be Covered In Clinical Trials Under Medicare Proposal
The proposed national coverage policy, which was generated from an internal request by the US Medicare agency, would provide Medicare coverage of leadless pacemakers only if they are part of an FDA-approved trial that evaluates peri-procedural complications, post-procedural complications, long-term outcomes, and the influence of patient characteristics on outcomes.
St. Jude Pauses LEADLESS II Trial Of Nanostim Following Reports Of Lost Telemetry
No patient injuries related to the Nanostim issues have been reported, but it puts St. Jude further behind Medtronic and Boston Scientific in the emerging leadless pacemaker market. The company says the problem reported with seven Nanostim devices is not related to the lithium-deposit problem that recently caused batter depletion in some of its high voltage devices.