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.
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Results from "real-world" registries of established devices, along with encouraging early results from novel devices were among the highlights of Heart Rhythm 2017, the annual scientific sessions of the Heart Rhythm Society, held in Chicago May 10-13.
Abbott Laboratories has finalized its $25b takeover of St. Jude Medical, first announced in April, making Abbott a major player in almost every corner of the $30bn cardiovascular device market.
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.