Medical Device Network

Abbott scores FDA approval for small, long lasting rechargeable DBS

Abbott’s Libera RC deep brain stimulation (DBS) device can be used to treat movement disorders including Parkinson's disease and essential tremors.

Abbott has received approval from the US Food and Drug Administration (FDA) for its Libera RC deep brain stimulation (DBS) device.

The Liberta RC DBS system can be used to treat various movement disorders including Parkinson's disease and essential tremors. The device is a small, rechargeable device that connects with Abbott's proprietary NeuroSphere Virtual Clinic to allow for remote monitoring and programming for the Libera device.

The Liberta RC DBS system is approximately the size of a smartwatch. It needs about 10 recharge sessions in a year or 30-minute charging sessions every week when used under standard settings, as per Abbott. The system can be worn while wirelessly charging and stays active throughout. The devicecan be controlled either via an Abbott-supplied patient controller or a compatible and secure iOS device.

"When our patients choose a rechargeable DBS system, it is often based on the smaller size of the device, but the tradeoff has always been how recharge frequency affects their lifestyle," said Dr. Paul Larson, professor of neurosurgery at the University of Arizona.

"The Liberta RC DBS system excels in both areas, as a compact rechargeable device with the lowest recharge requirement of any FDA-approved DBS system. This achievement, coupled with the integration of remote programming capabilities, is a significant advancement for patients."

Abbotthas another DBS system, Infinity DBS, as part of its portfolio. However, the device has suffered recent drawbacks and was part of a Class I recall after complaints that users were unable the exit the magnetic resonance imaging (MRI) mode.

Another brain stimulation device currently in development is Nexalin Technology’s HALO Clarity 15 milliamp (mA) neurostimulation device. The device targets deep mid-brain structures and can be used to treat multiple mental health conditions such as major depressive disorder (MDD), Alzheimer’s disease, chronic pain, and stress-related neuropsychiatric disorders. Nexalin is planning clinical trials for the HALO device to gain FDA approval.