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 in which 98.3% of Micra patients who reached the six-month follow-up point showed an adequate pacing capture threshold. A post-hoc analysis showed that the patients treated with Micra had lower risk of complications compared to patients treated with a traditional transvenous pacemaker in an historical control group.

As a condition of approval, Medtronic has agreed to conduct a post-approval study with at least 1,830 “real-world” patients, according to the company. The study investigators will evaluate one-month complication rates in at least 1,741 patients implanted with Micra and track the long-term performance of the device in at least 500 patients for a minimum of nine years, according to the company. These primary endpoints will also be analyzed at different times once the appropriate sample size is enrolled.

The company also expects to collect data on at least 200 patients undergoing device replacements or removals.

The FDA’s requirement that the Micra post-approval trial should be large enough to quantify the risk of rare adverse events within reasonably narrow intervals follows the advice of the agency's Circulatory System Devices Advisory panel. At its Feb. 18 meeting, the committee recommended that the post-approval trial of Micra last at least 10 years and enroll 1,700 patients or more, not including patients enrolled in premarket trials. (See [A#01160229003].)

The panel’s recommendations applied both to Medtronic’s Micra and St. Jude’s Nanostim. At its Feb. 5 investor conference, St. Jude told its shareholders that it expects the FDA to approve Nanostim – based on the results of the LEADLESS II trial – in time to launch the device in the US market in the second half of 2016. (See [A#01150907003].)

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

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