Medtronic gets FDA nod for next-gen, MRI-friendly pacer

Medtronic gained FDA approval for the Advisa DR MRI SureScan pacer.--Courtesy of Medtronic

Medtronic ($MDT) gained FDA approval for what will become its second MRI-friendly pacer in the United States, and only the second device of its kind to gain a regulatory nod here. Plans call for immediately rolling out the Advisa DR MRI SureScan pacer for marketing.

How time flies. Barely two years ago, Medtronic won the FDA's sign-off for the Revo MRI SureScan pacing system, the first MRI-friendly pacer kind to gain approval in the U.S. (Traditional pacemakers aren't MRI friendly). But a lot has changed in the market since then. Since 2011, Medtronic obtained a CE mark for Revo, and aggressively pursued development and testing of the next-generation Advisa MRI both abroad and in the U.S. And competition is rising; Rival St. Jude Medical ($STJ), for example, is pursuing a broad clinical trial for the Accent MRI, its own full-body MRI friendly pacemaker designed to allow widespread MRI scans rather than just at certain measurements and spots in the body. And Biotronik gained FDA approval in January to begin a U.S. clinical trial for its own MRI-safe pacemaker.

Medtronic's win of a second FDA approval for an MRI-friendly pacemaker is also noteworthy because it has been harder for these devices to pass regulatory muster here. The company, by contrast, has been selling SureScan-related pacers in Europe since 2008.

For Advisa MRI, the company won U.S. regulatory approval based on a pivotal trial involving 156 patients (fitted with special MRI-friendly leads). None of the patients were left with MRI-related problems, according to the company. Advisa MRI also has a number of updated bells and whistles, including technology designed to extend the device's lifespan, and diagnostics software that helps physicians detect and treat atrial fibrillation on the early side.

MRI-friendly implants and medical devices are becoming increasingly important to global healthcare. As many as 75% of patients globally who have implanted cardiac devices will need an MRI scan sometime during the life of their devices, Medtronic notes.

- read the release

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