Abbott’s Infinity Deep Brain Stimulation (DBS) system has received an expanded clearance from the FDA that now permits the targeted stimulation of a new area of the brain associated with Parkinson’s disease symptoms.

By now targeting the internal globus pallidus alongside the subthalamic nucleus and ventral intermediate nucleus, the company says that its system “is now the only directional DBS system approved for all major targets used to treat movement disorders, Parkinson's disease and essential tremor.”

The Infinity Deep Brain Stimulation system connects via Bluetooth to an iPad mini, through which clinicians can program their patients’ therapy and monitor outcomes on Abbott’s software platform. Patients, meanwhile, manage their systems using an iPod touch-powered controller for the device. The system has a CE Mark, and according to Abbott is available in “nearly 30 countries.”

WHAT’S THE IMPACT

Abbott’s system looks to help patients more easily manage symptoms that are not otherwise controlled by medications. The company said in its announcement that the new indication makes its offering a more appealing, and potentially effective, choice for those interested in treating themselves using a familiar controller device.

"The internal segment of the global pallidus ... is a well-established valuable DBS target for the management of the motor signs associated with Parkinson's disease, and is a preferred target for many patients, particularly for those with troublesome medication-induced dyskinesia," Dr. Jerrold Vitek, center director of the University of Minnesota Udall Center of Excellence for Parkinson's Research and head of its Neurology Department, said in a statement provided by Abbott. "This approval expands the options for patients to tailor treatment to their unique needs, with the added benefits of being able to target precise areas and utilizing a patient-friendly iOS device.”

THE LARGER TREND

The new indication helps Abbott’s device stand out from Medtronic’s offering, which was cleared in 2018 for use with an app interface and saw a US launch in late October. Like Abbott’s system, Medtronic’s offering connects to smart devices, but relies on Samsung’s Knox security platform rather than an iOS-based system.

ON THE RECORD

"The approval of Abbott's Infinity DBS system with targeted stimulation is a significant advancement for people living with Parkinson's disease and their care teams,” Dr. Binith Cheeran, director of medical affairs and deep brain stimulation at Abbott, said in a statement. “The ability to optimize the programming for each individual opens the door for a new standard of care for DBS therapy."