ANS Given IDE Approval to Investigate Libra DBS for Parkinson's

Advanced Neuromodulation Systems (ANS) has received an FDA investigational device exemption (IDE) approval to implant 136 patients at 12 sites with the ANS Libra Deep Brain Stimulation (DBS) System to investigate the product's safety and efficacy in treating Parkinson's disease.

The specific purpose of ANS' study for Parkinson's disease is to demonstrate the safety and efficacy of bilateral stimulation of the subthalamic nucleus when using the ANS Libra DBS System as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.

The company has identified a number of sites for the clinical study. The first implants of the Libra Implantable Pulse Generator System are anticipated to occur in the second quarter of this year.