Medtronic to present Micra data at FDA leadless pacer committee meeting

Medtronic (NYSE:MDT) said today it will present data on its Micra transcatheter pacing system at an FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee.

The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing, Medtronic said. The Micra device has an estimated 12-year battery life and is approved as safe for full-body MRI scans, the company said.

The panel is meeting on Feb. 18 in Gaithersburg, Md. to discuss leadless cardiac pacemaker device technology and make recommendations on clinical trial research, post-approval study design and training requirements for the devices, according to the company.

In November, Medtronic touted the results of a clinical trial of the device, saying it met its primary and secondary endpoints. Results from the trial were presented at the American Heart Association’s scientific sessions meeting this week and published in the New England Journal of Medicine, Medtronic said.

Fridley, Minn.-based Medtronic said that 99.2% of patients in the trial were successfully implanted with the device. A total 96% of 725 patients experienced no major complications, which Medtronic said is 51% less than is seen in patients with conventional pacing systems.

Cardiac injuries occurred in 1.6% of patients, complications at the groin site in 0.7% and pacing issues in 0.3%. Medtronic said there were no dislodgments, no systemic infections and a 0.4% rate of system revisions.

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