FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Medtronic Announces Results of Pacing System Trial

Nov. 12, 2015

Medical device giant Medtronic announced that its Micra transcatheter pacing system met its safety and effectiveness endpoints in a trial of 744 patients.

In the trial, 96 percent of patients experienced no major complications, the Irish devicemaker says. In addition, Micra patients had 54 percent fewer hospitalizations than observed in the historical control group.

Medtronic adds that 98.3 percent of patients had low and stable pacing thresholds at six months, yielding a projected average longevity for the device of more than 12 years.

The device was awarded the CE Mark in April, but is not yet approved for use in the U.S. — Michael Cipriano