New FDA Nod Takes Abbott ’s Infinity Beyond Past Indications

Abbott Laboratories is adding some extra firepower to its neuromodulation offerings. The company said last week that its Infinity Deep Brain Stimulation [DBS] device received a nod from FDA to treat Parkinson’s disease symptoms. The newly approved indication specifically calls for the Infinity DBS to target an area of the brain called the globus pallidus (GPi). Abbott said the GPi plays an integral role in the motor function and can be targeted with DBS to improve Parkinson’s disease symptoms not adequately controlled by medication. Abbott said with this approval, the Infinity DBS is now the only directional DBS system approved for all major targets used to treat movement disorders, Parkinson's disease and Essential Tremor: the subthalamic nucleus (STN), ventral intermediate nucleus (VIM) and GPi. “The [new indication] is targeting people with Parkinson’s disease with symptoms that aren’t adequately controlled with medication,” Binith Cheeran, M.D., director of medical affairs, deep brain stimulation, a part of Abbott's neuromodulation business, told MD+DI. “It’s serving that patient population better so that you can customize the target treatment for better outcomes.” The company said Infinity is the first and only DBS system operating in these indications on an iOS software platform with Bluetoothwireless technolog...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Business Source Type: news