St. Jude Medical Announces Australian TGA Regulatory Approval For Libra Deep Brain Stimulation Systems For Parkinson's Disease

Main Category: Parkinson's Disease
Also Included In: Regulatory Affairs / Drug Approvals;  Neurology / Neuroscience
Article Date: 16 Jul 2009 - 0:00 PDT

email to a friend   printer friendly   opinions  

St. Jude Medical, Inc. (NYSE:STJ) announced Australian Therapeutic Goods Administration (TGA) approval of its Libra® and LibraXP™ deep brain stimulation (DBS) systems for treating the symptoms of Parkinson's disease, a neurological disorder that progressively diminishes a person's control over his or her movements.

Similar to a heart pacemaker, the Libra DBS systems function 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 which 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 are constant current devices that feature the largest battery capacity of any DBS device in their class, which may maximize the time between device replacement procedures. This therapy can be externally programmed by a clinician to meet individual patient needs.

An estimated 6.3 million people worldwide live with Parkinson's disease, according to the European Parkinson's Disease Association. The disease usually develops in people between the ages of 40 and 70, with an average age of onset of 60 years. Parkinson's disease affects both men and women in almost equal numbers, although research suggests that men are two to three times more likely to be diagnosed with the disease than women.

Parkinson's Disease Symptoms

Parkinson's disease patients may experience stiffness or rigidity of the arms and legs, slowness or lack of movement, and walking difficulties, in addition to tremor of the hands, arms, legs, jaw or face. These symptoms can make simple, everyday tasks like getting dressed, shaving, eating with utensils and drinking from a glass difficult. Faced with these challenges, Parkinson's disease patients often have a significant decline in their quality of life.

In addition to the TGA approval, the Libra and LibraXP DBS systems have also received the CE Mark approval in Europe. In the U.S., the systems are currently being evaluated in clinical studies for depression, Parkinson's disease and essential tremor. For more information about these studies, visit http://www.BROADENstudy.com, http://www.PowerOverPD.com and http://www.PowerOverET.com

Source
St. Jude Medical

• Additional
• References
• Citations