ANS Announces IDE Approval to Investigate Libra DBS System

Advanced Neuromodulation Systems (ANS) has received an FDA investigational device exemption (IDE) approval to implant 160 patients at 12 sites to investigate the safety and efficacy of the ANS Libra Deep Brain Stimulation (DBS) System to treat essential tremor.

ANS has identified a number of sites for the clinical study. The first implants of the Libra system are anticipated to occur in the second quarter of this year.

The company also announced the submission to the FDA of an amendment to its IDE application to investigate the ANS Libra DBS System to treat Parkinson's disease. ANS anticipates receiving this IDE approval from the FDA in the second quarter.