FDAnews Device Daily Bulletin

Medtronic’s SureScan Pacing Systems Receive FDA Clearance

Jan. 24, 2014

Medtronic said Wednesday the FDA has OK’d its Advisa DR MRI and Revo MRI SureScan second-generation pacing systems for use during magnetic resonance imaging of any part of the body, including the chest— the first and only pacing systems in the U.S. to win such a broad indication.

The agency’s decision followed computer modeling and clinical studies of more than 700 patients across the U.S., Europe, the Middle East, Canada and Australia to evaluate the pacemakers’ safety and efficacy during MRI scans. All endpoints were met in all of the trials and there were no MRI-related complications, said Medtronic spokesman Joey Lomicky.

The internal circuitry of the SureScan pacemaker is designed to prevent MRI forces from disrupting the device’s function, while highly reduced amounts of ferromagnetic components decrease magnetic attraction between the device and scanner, according to the company. The lead tips are designed especially to prevent interaction between gradient field energy and radiofrequency energy, lowering the chances that the former might induce cardiac stimulation.

As many as 75 percent of people with pacemakers will need an MRI at some point in their life, Medtronic said. “This approval allows for a broader range of MRI scans for patients with these pacemakers … [and] will make it easier for them have chest scans,” Lomicky said.

Medtronic’s first-generation Revo and second-generation Advisa pacemakers were cleared for use in MRIs excluding the chest area in Feb. 2011 and Jan. 2013, respectively. — Lena Freund

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