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.
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HRS 2017: Medtronic And Boston Scientific's Less-Invasive CRM Devices Perform As Hoped In Real-World Registries
Results from the post-approval trials of Medtronic's Micra Transcatheter Pacing System and Boston Scientific's S-ICD presented at the Heart Rhythm Society Scientific Sessions in Chicago show these "leadless" devices can be implanted in "real world" patients with acute outcomes similar to those of the pre-market trials that had more restrictive inclusion criteria.
The medtech giant announced 6% revenue growth, led by the cardiac and vascular and diabetes groups, both of which are enjoying strong market demand for new products. Medtronic expects to continue growing revenues by about five percent annually to maintain double-digit earnings growth.
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.