Medtronic’s Micra Lands FDA Approval, As First Leadless Pacemaker in U.S.

The FDA gave the green light last week to what is now the world’s smallest pacemaker: Medtronic’s Micra transcatheter pacing system.

The Micra is a self-contained, inch-long device that is intended for use in patients who need a single-chamber pacemaker. It will allow patient data to be sent remotely to clinicians through the Medtronic CareLink Network. Remote monitoring is expected to be available later this year.

The approval is based on a 719-patient clinical trial in which 98 percent of patients had adequate heart pacing six months after the device was implanted. Complications occurred in fewer than 7 percent of participants and included prolonged hospitalizations, blood clots in the legs and lungs, heart injury, device dislocation and heart attacks.

The FDA has expressed concerns about the long-term safety of the devices. In February, the FDA’s Circulatory System Devices Panel advisory committee recommended that long-term postapproval studies enroll a large number of patients for the devices (IDDM, Feb. 26).

The clinical trial will continue to follow patients for at least 12 months to evaluate long-term performance of the device, the FDA says.

More than 30 centers in the U.S. have experience with Micra implantation, as a result of participating in the clinical trial evaluating the device. A limited amount of product will ship in late April or early May to these sites, as physicians have satisfied training requirements through trial participation, says Medtronic spokesman Ryan Mathre.

“We will immediately begin scheduling training new physicians on the procedure which will occur after the Heart Rhythm Conference in May, with product shipment to these new accounts to follow soon after,” he tells IDDM.

The Micra was awarded the CE Mark in April 2015 based on early clinical trial data.