Medtronic wins FDA nod, launches Advisa SR MRI-safe pacer

Medtronic (NYSE:MDT) said today that it won FDA approval for its Advisa SR MRI-safe SureScan single-chamber pacemaker, and that it is launching the device in the U.S.

The device will allow MRI scans of any region of the body as long as it is used with MRI-safe SureScan leads, the Fridley, Minn.-based company said.

“MRI is a vital diagnostic tool that was not available to pacemaker patients before Medtronic released the world’s first MR-conditional pacing system in 2008. Through our work with clinicians, Medtronic MR-conditional pacing systems have been evaluated in 4 clinical studies with more than 3,600 patients, and today we offer the most extensive portfolio of MR-conditional pacing devices and leads available in the U.S.,” veep of Medtronic’s bradycardia business Brian Urke said in a press release.

Medtronic said the new MRI-safe pacemaker also has improved diagnostic information and storage and a 35% improvement in battery life over the company’s Adapta single-chamber pacer.

An estimated 50% to 70% of patients with implantable cardiac devices will need an MRI scan during the life of the device, the company said.

In April, Medtronic said the FDA expanded the indication for some of its cardiac rhythm management devices to include bi-ventricular pacing in certain heart failure patients.

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