Abbott receives CE mark of MR-conditional labelling for Infinity deep brain stimulation system


Parkinson’s disease, dystonia and essential tremor patients in CE Mark countries will now benefit from upgraded functionality and new magnetic resonance (MR) conditional labelling of Abbott’s Infinity deep brain stimulation (DBS) system. Abbott has announced that the company has received CE mark for a Bluetooth-enabled software upgrade for all currently implanted Infinity DBS systems that delivers MR-conditional labelling and innovative features.

Prior to this approval, people new to DBS therapy or those living with older systems from other manufacturers may have experienced barriers in accessing the most advanced DBS therapy options because of the potential need for an MRI in the future. With its updated labelling, Abbott has addressed this challenge with the Infinity DBS system’s improved therapy platform—the first and only MR-conditional directional DBS system available globally.

“We developed the Infinity DBS platform to allow over-the-air software updates, and this is why patients who were implanted two years ago are able to benefit from Abbott’s latest advances today—without the requirement of repeat invasive surgery,” said Binith Cheeran, medical director of movement disorders at Abbott. “We are committed to continued innovation in neuromodulation, developing efficiencies for physicians and, therapy advances for people who are battling movement disorders so that they can live fuller lives.”

This new CE mark allows Infinity DBS systems that are currently implanted to be upgraded via secure Bluetooth wireless technology without the need for surgery, giving full-body MR-conditional labeling to the Infinity DBS system, along with the suite of system upgrades. Abbott’s new Informity Programming Software is designed to help clinicians streamline the programming process with an iPad mini device to become more efficient in their practice and achieve optimal programming with directional leads. New implants of the Infinity DBS systems going forward will also have MR-conditional labelling.

“Abbott’s response to physician feedback resulted in significant innovation for treating patients with progressive diseases. This new advance of MR-conditional labelling and upgradability with the Infinity’s directional DBS system ensures that we can offer continual therapy advancements for improved outcomes,” said Vincent d’Hardemare, a neurosurgeon at Fondation Ophtalmologique Rothschild in Paris.


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