Medtronic's Micra TPS Data to Be Presented at FDA Advisory Committee Meeting

January 29, 2016—Medtronic plc announced that the company will present data on its Micra transcatheter pacing system (TPS) at the US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee on February 18, 2016, in Gaithersburg, Maryland. The FDA committee will meet to discuss and make recommendations on clinical trial research, postapproval study design, and physician training requirements for this leadless cardiac pacemaker device technology. More information about the meeting is available on the FDA website.

In November, Medtronic announced that results from the Micra TPS Global Clinical Trial were presented at the 2015 American Heart Association Scientific Sessions and published online ahead of print in The New England Journal of Medicine.

In the clinical data presentation, the MicraTPS was successfully implanted in nearly all patients (99.2%) and exceeded safety and effectiveness endpoints with wide margins. Most patients (96%) with the Micra device experienced no major complications; there were no dislodgments, no systemic infections, and very few (0.4%) revisions (extraction, repositioning, or replacement). Major complications included cardiac injuries (1.6%), complications at the groin site (0.7%), and pacing issues (0.3%).

The study included a comparison of Micra TPS safety performance to a predefined, historical control group consisting of more than 2,500 patients who received conventional pacing systems. Compared to patients with conventional pacing systems, the patients in the Micra trial were older and had more comorbidities, yet had fewer major complications, advised the company.

According to the company, the Micra TPS is less than one-tenth the size of traditional pacemakers and cosmetically invisible, yet provides the most advanced pacing technology available. It is implanted directly into the heart and does not require the use of leads to deliver pacing therapy, thereby reducing potential sources of complications seen with conventional pacing systems.

In April, the company announced European CE Mark approval for the Micra TPS. In the United States, the Micra TPS is an investigational device and is not yet approved for commercial use, advised Medtronic.