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FDA Approves Medtronic's Leadless Pacemaker With Large Postmarket Trial Condition

As a condition of approval for the Micra pacer, Medtronic has agreed to conduct a post-approval study with at least 1,830 “real-world” patients, according to the company.

FDA approved Medtronic’s Micra transcatheter leadless single-chamber pacemaker, beating out St. Jude’s Nanostim to be the first transcatheter leadless pacemaker to earn FDA approval.

The April 6 PMA approval is based primarily on the results of a 725-patient trial

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