FDA Approves Medtronic's Micra Transcatheter Pacemaker System

April 6, 2016—Medtronic plc announced that it has received US Food and Drug Administration (FDA) approval of the Medtronic Micra transcatheter pacing system (TPS). The device provides a safe alternative to conventional pacemakers without the complications associated with cardiac leads. Micra TPS is approved for both 1.5 and 3 Tesla full-body magnetic resonance imaging scans, stated the company.

In April 2015, Medtronic announced that the Micra TPS received European CE Mark approval. 

Medtronic noted that the Micra TPS is comparable in size to a large vitamin pill. It is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. The Micra TPS does not require leads or a surgical pocket under the skin, so potential sources of complications related to such leads and pocket are eliminated, as are any visible signs of the device. The device responds to patients' activity levels by automatically adjusting therapy.

The Micra design incorporates a retrieval feature to enable retrieval when possible; however, the device is designed to be left in the body. For patients who need more than one device, the Micra TPS can be permanently turned off so it can remain in the body and a new device can be implanted without risk of electrical interaction.

The Micra TPS is intended for use in patients who need a single-chamber pacemaker. The device was designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink Network; remote monitoring of Micra devices is expected to be available later this year, advised the company.

Approval of the device was supported by data from the Medtronic Micra TPS Global Clinical Trial. Dwight Reynolds, MD, Regent’s Professor and Chief of the Cardiovascular Section at the University of Oklahoma Health Sciences Center, served as Principal Investigator in the trial.

In Medtronic’s press release, Dr. Reynolds commented, “For many years we've been hopeful that a transcatheter pacing solution—with a safety and effectiveness profile on par with conventional devices—would become available, and today Micra has achieved this milestone.”

Dr. Reynolds continued, “In the clinical trial, the Micra was successfully implanted in nearly all patients, and met its safety and effectiveness endpoints by wide margins. This gives us great confidence that this miniaturized device will bring patients the most advanced pacing technology, combined with the less-invasive nature of the new technology.”

In November 2015, Medtronic announced that data from the Micra TPS data were presented during a late-breaking Special Report session at the American Heart Association’s Scientific Sessions 2015 in Orlando, Florida, and simultaneously published by Dr. Reynolds et al in The New England Journal of Medicine (2016;374:533–541). 

In January 2016, the company announced it would present the data to the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee, which met on February 18 to discuss and make recommendations on the clinical trial research, postapproval study design, and physician training requirements for this leadless cardiac pacemaker device technology.