Medtronic To Conduct Clinical Trial of New Pacing System

Medtronic, Inc. has received approval from the U.S. Food and Drug Administration (FDA) to launch a clinical trial of the Advisa DR MRI (magnetetic resonance imaging) Sure Scan pacing system. The approval makes the company the first in the United States to conduct a randomized, controlled clinical trial of a second-generation pacing system designed for use in the MRI environment under specific scanning conditions.

Until last February, MRI procedures were contraindicated in patients with implanted pacemakers due to the risk of adverse events. Then, the FDA approved the Revo MRI SureScan pacing system. Although the Revo was deemed safe for these patients, it could not produce a complete chest scan. The Advisa offers improvement in that area.

“Currently, physical isocenter positions between vertebrae C1 (cervical) through T12 (thoracic) are excluded from the Revo MRI indication,” said Wendy Dougherty, Medtronic spokesperson. “The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness of the Advisa MRI System in the clinical MRI environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions, as well as provide data on MRI image quality in the presence of the pacemaker system.”

The trial can enroll up to 250 patients in 50 medical centers across the United States, Europe, Central Asia, Canada and Australia, Dougherty said.
“The FDA approval of the Advisa MRI System Study protocol brings us one step closer to providing patients with another pacemaker option designed for safe use in the MRI environment,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic, in a company statement.