Medtronic snags EU approval for an MRI-safe ICD

Medtronic's Evera ICD

Medtronic ($MDT) is headed to the European market with what it says is the first implantable defibrillator cleared for full-body MRI scans, following a widespread trend toward imaging-safe implants.

The company picked up a CE mark for an MRI-friendly version of its Evera ICD, Medtronic's third scan-safe cardiac device after the pacemakers Advisa and Revo. Implanted devices have long been contra-indictated for magnetic imaging due to worries that the procedures will hamper their function and put patients at risk. Roughly 63% of ICD implantees will need an MRI within a decade of getting their device, according to Medtronic, thus creating an unmet need that has galvanized the industry.

However, unlike anything on the market from rivals like St. Jude Medical ($STJ) and Biotronik, Medtronic's latest scan-safe device is indicated for use in full-body procedures, the company said.

"This means that in addition to having the highest standard in modern ICD treatment, patients implanted with an Evera MRI defibrillator will now have improved access to one of the most important diagnostic tools--the MRI," Medtronic Vice President Marshall Stanton said in a statement.

Beyond its MRI compatibility, Evera is outfitted with Medtronic's SmartShock technology--designed to cut back on errant jolts of energy--and a contoured design that reduces patient skin pressure by 30%, according to the company. The FDA approved a non-MRI version of the device last year, but the scan-safe version has yet to win agency approval.

Meanwhile, Medtronic is still struggling to chart some growth in its cardiac device business. Last quarter, its defibrillator revenue stayed about flat at $655 million while pacemaker sales dipped 2% to $439 million.

- read the statement

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