Medtronic's Leadless Pacer Gets CE Mark

 Marie Thibault

Medtronic's Micra Transcatheter Pacing System, a leadless pacemaker that is also the smallest in the world, has received CE Mark approval. The single-chamber pacer is less than one-tenth of the size of a traditional pacemaker, about the size of a large vitamin, according to a company news release.

Micra does not have lead wires, and is implanted into the heart through a catheter. Eliminating leads is a good thing for patients, since lead migration and the potential need for extraction can lead to complications. Philippe Ritter, MD, cardiologist at Hopital Cardiologique de Haut Leveque and Centre Hospitalier Universitaire Bordeaux, explained in the release that in addition to eliminating leads, "unlike traditional pacemakers, the Micra TPS does not require leads or a surgical 'pocket' under the skin, so potential sources of complications are eliminated—as are any visible signs of the device." 

Micra is the second leadless pacemaker to receive CE Mark. St. Jude's Nanostim leadless pacemaker has had CE Mark approval since October 2013.

Medtronic's Micra is implanted in the heart using a catheter snaked through the patient's femoral vein. Once positioned in the right ventricle of the heart, small tines are used to attach the device to the heart wall. Pacing is delivered using an electrode at one end of the pacemaker. According to the release, Micra is repositionable and retrievable, another advantage over traditional pacemakers. In addition, the leadless pacemaker is fully compatible with MRI scans and has an approximately 10-year battery life.  

Micra is being studied in a 780-patient global trial. CE Mark approval was granted after review of three month results from the first 60 patients in this trial. Early data from the trial will be presented at the Heart Rhythm Society annual meeting next month. 

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of Medtronic Plc]