The first controlled study on deep brain stimulation (DBS) conducted by St. Jude Medical evaluates the safety and effectiveness of Libra and LibraXP DBS constant current systems in managing the symptoms of Parkinson's disease (PD).
The Libra and LibraXP systems comprise a neurostimulator, a surgically implanted battery-operated device that produces mild electrical pulses and leads to a targeted area in the brain.
The DBS study conducted at 15 medical centers in the US enrolled 136 patients, who on average had suffered from PD for at least five years and who had six or more hours each day with diminished motor symptom control and with moderate to severe dyskinesia.
The trial demonstrated that patients receiving stimulation had a 73% response rate compared to a 38% response rate in the group without stimulation, while motor scores for those in the stimulation group showed 39% improvement compared to the baseline.
The study also showed that participants in the stimulation group averaged an increase of 4.27 hours of "on time," compared with an increase of 1.77 hours in the group without stimulation.
St. Jude Medical Neuromodulation Division president Rohan Hoare said the results confirm the benefit of the constant current deep brain stimulation device platform and lay the foundation for future therapy innovation.
The Libra and LibraXP neurostimulators are currently approved for use in Europe, Latin America and Australia for managing the symptoms of PD.