FDA Approves Micra, First Leadless Pacemaker for US Patients

April 06, 2016

WASHINGTON, DC — The Micra Transcatheter Pacing System by Medtronic has become the first leadless pacemaker system to be approved in the United States[1]. The US Food and Drug Administration (FDA) announced the approval almost 2 months after convening an advisory panel to work out the practice issues of such devices, which as a class are potentially transformative for pacing therapy but in current generations remain less sophisticated than most standard pacemakers.

Both Micra and a competing device, the Nanostim , from St Jude Medical, which remains investigational in the US, are approved in Europe. Both devices are implanted by catheter into the right ventricle, ideally near the apex, to provide single-chamber pacing without need for the wired lead system integral to standard subcutaneously implanted pacemakers. Such standard leads are associated with some of the more serious complications associated with pacemaker implants, including infection.

The FDA approval announcement cited the influence of the Micra TPS Global Clinical Trial of 719 patients implanted with the device, in which 98% of patients had adequate pacing capture thresholds and only 4% experienced major complications associated with the device. That compared with a major complication rate of 7.4% (P=0.001) in a propensity score-matched historical control group of patients receiving standard pacemakers.

As reported previously by heartwire from Medscape, Micra in the trial was also associated with about 40% as many hospitalizations, an 88% drop in need for system revisions, and no instances of pneumothorax or dislodgments from its anchor within the right ventricle.

As noted by the FDA, Micra is contraindicated for patients with other implanted cardiac devices that might interfere with its sensing performance and patients with femoral venous anatomy that won't accommodate the 23 F introducer sheath.


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