Medtronic Micra Transcatheter Pacemaker Meets Safety Measures
Medtronic announced Friday that its Micra transcatheter pacing system met clinical safety and performance measures.
The first 140 patients in the Micra TPS global trial featured a wide range of conditions, including chronic obstructive pulmonary disease and pulmonary hypertension, the company says. Mean electrical pacing measurements at one- and three-month follow-ups came in at expected ranges for every patient.
Medtronic’s global trial will eventually enroll up to 780 patients at an estimated 50 centers across 20 countries.
The device is the size of a large vitamin, or less than one-tenth the size of most pacemakers. It won CE Mark approval last month. In the U.S., it has been designated for investigational use only. — Jason ScottMedical Devices Research and Development