St. Jude Medical, Inc. announced the completion of patient implants in its US pivotal clinical study of deep brain stimulation (DBS) for the symptomatic treatment of Parkinson’s disease, a neurological disorder affecting approximately 6.3 million people worldwide that progressively diminishes a person’s control over his or her movements. The announcement was made at the Movement Disorder Society’s 13th International Congress of Parkinson’s Disease and Movement Disorders in Paris.
“We are excited by the progress we’ve made in bringing the Libra deep brain stimulation systems to the market,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “The completion of patient implants in this study and our recent European CE Mark approval represent significant steps towards our goal of providing physicians with an innovative deep brain stimulation system for treating Parkinson’s disease.”
Ongoing at 15 medical centers in the US, this randomized, controlled study is evaluating the St. Jude Medical Libra and LibraXP DBS systems, to determine the devices’ safety and effectiveness in controlling many of the motor symptoms of advanced Parkinson’s disease. The study is following 136 participants who have lived with the disease for more than five years and whose symptoms were insufficiently controlled with medication alone.
“Ultimately patients benefit from the development of new technologies,” said Michele Tagliati, M.D., associate professor of neurology and division chief of movement disorders at Mount Sinai Medical Center in New York who enrolled the first patient in the study. “We are hopeful the Libra deep brain stimulation systems will prove effective at reducing the symptoms of Parkinson’s disease and provide additional tools to better control this debilitating condition.”
The Libra and LibraXP neurostimulators are constant current devices. The systems consist of a neurostimulator – a surgically implanted battery-operated device that generates mild electrical pulses – and leads, which carry the pulses to a targeted area in the brain.
“The progressive nature of Parkinson’s disease often leads patients to a point where medication management alone can no longer adequately control the symptoms of the disease,” said Bruno Gallo, M.D., assistant professor of neurology at the University of Miami in Florida and an investigator in the study. “Because these patients often become unable to care for themselves, we need to look for additional methods of treating this debilitating condition in order to help improve a patient’s quality of life.”
The National Parkinson Foundation estimates that in the US, more than 1.5 million people currently have the disease with 60,000 new cases diagnosed each year. According to the European Parkinson’s Disease Association, as many as 6.3 million people are estimated to be affected by this disease worldwide.