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St. Jude Pauses LEADLESS II Trial Of Nanostim Following Reports Of Lost Telemetry

 
• By Reed Miller

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.

St. Jude Medical Inc. has paused patient enrollment in the LEADLESS II clinical trial of its Nanostim leadless pacemaker after receiving seven reports of the devices losing telemetry and pacing.

LEADLESS II is a non-randomized, single-arm, international multicenter trial of Nanostim planned for 667 patients indicated for VVIR pacing (demand ventricular pacing with physiologic response to exercise). Nanostim has a...

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More from Policy & Regulation

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• By Neena Brizmohun

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