Medtronic will present data on its Micra Transcatheter Pacing System to an FDA advisory committee on Feb. 18. The Micra, a miniature leadless pacemaker, is not yet FDA-approved.
In November, results of a trial evaluating the Micra were presented at the American Heart Association Scientific Sessions and simultaneously published online in the New England Journal of Medicine. At the time, Medtronic said it expected to hear about an FDA approval during fiscal year 2017, which begins in May 2016.
After six months of implantation with the Micra, 96 percent of patients did not have system-related or procedure-related major complications and 98.3 percent of the patients had a low and stable pacing capture threshold. In addition, the device was successfully implanted in 99.2 percent of patients.
On Feb. 18, Medtronic will present data in front of the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee. The meeting, which is open to the public, will take place at the Hilton Washington DC North hotel Gaithersburg, Md.
“The Committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology,” the committee said in a posting on its website. “Specifically, the Committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection.”