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Medtronic’s Micra transcatheter pacing system shows low complication rate in PAR study

MDBR Staff Writer Published 10 May 2018

Medtronic’s Micra transcatheter pacing system (TPS) has demonstrated low complication rate in the post-approval registry (PAR) study.

Claimed to be world’s smallest pacemaker, Micra TPS is the only leadless pacemaker approved in the US.

The results of the PAR study demonstrated Micra TPS showed an implant success rate of 99.1% in clinical practice and low major complication rate of 2.7% through 12 months post-implant.

The data also demonstrated that Micra TPS is a safe and feasible pacing option for patients with a recent cardiac implantable electronic device (CIED) infection, said Medtronic.

Medtronic’s global Micra PAR is a prospective single-arm observational study designed to evaluate the safety and efficacy of the Micra TPS in the post-approval setting.

The company recruited 1,817 patients at 179 centers across 23 countries in the trial, which evaluated system or procedure-related major complications through 12 months following implant.

Later, the rates have been compared against major complication rates of the Micra IDE and to a reference dataset of 2,667 patients implanted with a transvenous pacemaker.

In April 2016, Micra TPS secured approval from the US Food and Drug Administration to be used for patients requiring a single-chamber pacemaker.

During the implant procedure, the pacemaker will be attached to the heart with small tines to generate electrical impulses that pace the heart through an electrode at the end of the device.

Micra TPS is said to be the first and only leadless pacing system secured approval for both 1.5 and 3 Tesla full-body magnetic resonance imaging (MRI) scans.

Medtronic cardiac and vascular group’s cardiac rhythm and heart failure division chief medical officer and vice president Dr Rob Kowal said: "Medtronic is committed to providing the most advanced technologies that improve lives of patients around the world.

"The leadless Micra pacemaker is an excellent example of one of those technologies, and now we know that it performs well for patients in a real world setting as well as in a clinical trial."

Image: Medtronic operational headquarters. Photo: courtesy of Medtronic.