Abbott wins FDA MR-conditional labeling for Infinity DBS

August 2, 2018 By Fink Densford Leave a Comment

Abbott (NYSE:ABT) said today it won expanded FDA approval for magnetic resonance conditional labeling for its Infinity Deep Brain Stimulation system designed to treat individuals with Parkinson’s disease and essential tremors.

The update will be delivered through an over-the-air software upgrade to all currently implanted Infinity DBS systems, the company said. Abbott touted that with the approval, the Infinity DBS is the first and only FDA-approved MR-conditional directional DBS system.

“With this software upgrade, Abbott delivers on a promise to develop powerful features that strengthen the Infinity DBS system’s already patient-centric platform, which uses familiar Apple technology and frees the patient from recharging their device. We are committed to continued innovation in neuromodulation, developing ongoing advancements and efficiencies for physicians and, most importantly, helping thousands of people who are battling movement disorders live fuller lives,” Abbott movement disorders medical director Dr. Binith Cheeran said in a press release.

The approval will allow existing implants to be updated via bluetooth with no need for surgery, and allow individuals with the systems to undergo magnetic resonance procedures. The update also includes a number of system upgrades, Abbott said.

“Today’s announcement of the newly released MRI-compatibility of the Infinity DBS system reflects Abbott’s continued commitment to patient-centric, cutting-edge care – where the patient’s options are expanded by the therapy instead of limited by it,” Dr. Brian Kopell of New York City’s Center for Neuromodulation at Mount Sinai Health System said in a prepared statement.

Late last month, Abbott said that it launched a US-based pivotal clinical study of its Tendyne transcatheter mitral valve replacement system designed to treat mitral regurgitation.

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