Abbott wins MR-conditional label for Ellipse ICDs

Abbott (NYSE:ABT) said today that it won an MR-conditional label from the FDA for the Ellipse implantable cardioverter defibrillator it acquired along with St. Jude Medical early this year.

The MR-conditional label applies to Ellipse and the Tendril MRI pacing lead and the Durata and Optisure high-voltage leads, the Chicago-area medical device giant said.

“When you consider the number of patients each year who rely on the lifesaving treatment delivered by an ICD device, it is critical to continually innovate to provide new benefits to people battling complex arrhythmias and other cardiac conditions,” cardiac arrhythmias & heart failure CMO Dr. Mark Carlson said in prepared remarks. “By expanding our portfolio of MRI-compatible devices, we’re adding another benefit onto an ICD device that was designed hand-in-hand with physicians to optimize therapy for patients.”

St. Jude, which Abbott acquired for $25 billion in January, won CE Mark approval in the European Union for the MR-conditional label on Ellipse in May 2015.

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