FDAnews Device Daily Bulletin

Medtronic Implants First-in-Human Micra Transcatheter Pacemaker

Dec. 11, 2013

Medtronic conducted the first human implantation of its single-chamber Micra transcatheter pacing system in Linz, Austria, as part of an international clinical trial of 780 patients with bradycardia across 50 centers. Three-month results from the first 60 patients are expected in the second half of next year.

About 30 percent of pacemaker patients worldwide use single-chamber systems, said Medtronic spokesman Joey Lomicky. “We view this as really game-changing technology that will expand pacemaker technology to patients all over the world.”

The pacemaker — one-tenth the size of traditional pacemakers, or about the size of a large vitamin pill — is inserted via a catheter through the femoral vein, eliminating the need for an invasive surgical procedure. Once inside, the device is attached directly to the heart wall via tines, rather than into a pocket in the chest, which is the case with larger pacemakers. Its electrical stimulation comes from an electrode attached to the device, rather than from the leads found in standard pacemakers.

The Minnesota devicemaker is working with the FDA to bring clinical trials of the pacemaker to the U.S. in 2014. — Lena Freund