Micra Miniature Leadless Pacemaker Gains CE Mark Approval

April 14, 2015

DUBLIN, IRELAND — European physicians will now have access to a second leadless pacemaker, as Medtronic announced today the Micra transcatheter pacing system (TPS) has gained CE Mark approval in Europe[1].

The Micra, which is not much larger than a one Euro coin (or nickel) at one-tenth the size of a traditional pacemaker, was approved in Europe as part of the Micra TPS Global Clinical Trial, a larger ongoing study. For the CE Mark approval, European regulators approved the device on safety and efficacy outcomes of 60 patients who had the tiny pacemaker implanted and were followed for 3 months.

The device, which is delivered via catheter and eliminates the traditional surgical "pocket," is not approved in the US, but researchers plan to enroll as many as 780 patients from 50 clinical centers as part of the ongoing global trial.

Dr Philippe Ritter (Hôpital Cardiologique de Haut Lévêque/Centre Hospitalier Universitaire, Bordeaux, France) will present initial results from the global clinical trial—those that led to the CE Mark designation—at the Heart Rhythm Society's 2015 Scientific Sessions in May.

Micra TPS [Source: Medtronic]

In 2013, the Nanostim leadless cardiac pacemaker (St Jude Medical) gained CE Mark approval and is also available for use in Europe. Like the Micra, the Nanostim is not commercially available in the US. As reported by heartwire , the LEADLESS II study with Nanostim had been halted after reports of six perforations, two of which resulted in patient deaths. The study has since resumed, however, after investigators altered the exclusion/inclusion criteria.

The two pacemakers—Micra and Nanostim—differ slightly in terms of how they are lodged into the myocardium of the right ventricular apex.

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