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St. Jude Medical Receives TGA Regulatory Approval For Libra Deep Brain Stimulation Systems For Parkinson’s Disease

St. Jude Medical, Inc announced that it received Australian Therapeutic Goods Administration (TGA) approval for Libra and LibraXP deep brain stimulation (DBS) systems for treating the symptoms of Parkinson’s disease.

The company’s Libra DBS systems work by delivering mild electrical pulses from an implanted device via thin wires with multiple independent electrodes. The stimulation is targeted to one of three regions in the brain that are involved in muscle control for the symptomatic treatment of Parkinson’s disease.

“This approval is an important step forward in bringing our deep brain stimulation systems to a broader market,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “We are excited to be able to provide physicians in Australia with these best-in-class deep brain stimulation systems, allowing them to have more capability and control in treating their patients.”

The Libra and LibraXP neurostimulators features a large battery capacity that may maximize the time between device replacement procedures. To meet individual patient needs, this therapy can be externally programmed by a clinician.

The Libra and LibraXP DBS systems have also received the European approval. These systems are currently being evaluated in clinical studies for depression, Parkinson’s disease and essential tremor in the US.