Medtronic Announces Results from Initial Micra TPS Implants

June 19, 2014

Medtronic Thursday reported initial results from a clinical trial of the Micra transcatheter pacing system, saying the first four patients implanted with the device had no major post-implant complications at one and three months. The patient’s ages ranged from 74 to 83.

The single-arm, multicenter Micra TPS Global Clinical Trial will eventually enroll up to 780 patients at 50 centers. The first patient implant took place last December in Linz, Austria, and the first U.S. implant was performed in February at New York University Langone Medical Center, said Medtronic spokesman Joey Lomicky.

Results from the first 60 patients, followed up to three months, are expected in the second half of fiscal year 2015, Lomicky said.

One-tenth the size of a normal pacemaker, Micra TPS is transported directly into the heart via a catheter inserted into the femoral vein, eliminating the need for a surgical incision — a potential source of complications. Once positioned, the pacemaker is securely attached to the heart wall and can be repositioned or retrieved as needed. In place of wires, small tines secure the device to the heart and deliver electrical impulses. — Kellen Owings

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