European regulators have given a green light to St. Jude Medical to market the company’s Libra® and LibraXP™ deep brain stimulation (DBS) systems for treatment of symptoms of Parkinson’s disease. It was just last year when we had two posts about Libra DBS stimulators, as we discussed how these devices are thought to be effective for the treatment of severe cases of bipolar disorder (see this post and this one).
From today’s press release by St. Jude:
The limited launch of these systems in Europe marks St. Jude Medical’s first products in the DBS market.
The Libra DBS systems function in a manner similar to a heart pacemaker by delivering mild electrical pulses from an implanted device to stimulate structures in the brain that are involved in muscle and movement control. Stimulation is delivered to one of two regions in the brain known as the subthalamic nucleus (STN) or the globus pallidus interna (GPi) to influence nerve cell activity in these regions.
"The approval of our first deep brain stimulation system represents the fulfillment of a milestone for St. Jude Medical as we continue to deliver on our promise to develop therapies to treat neurological conditions," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division.
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 non-invasively adjusted by a clinician to meet individual patient needs.
"We have a long history in the development of neurostimulation therapies with more than 45,000 people implanted with our devices for chronic pain," adds Chavez. "We look forward to providing physicians with this innovative deep brain stimulation system that allows them to better control the symptoms of this debilitating disease."
Parkinson’s disease affects an estimated 6.3 million people worldwide, according to the European Parkinson’s Disease Association. Research suggests that men are two to three times more likely to be diagnosed with the disease than women. The National Parkinson’s Foundation estimates that 1 in every 100 people in the U.S. over the age of 65 has the disease.
A recent study published in the Journal of the American Medical Association concluded that DBS was a more effective treatment than best medical therapy for the management of moderate to severe Parkinson’s disease.
St. Jude Medical is also currently developing new DBS applications to address a growing list of neurological disorders. Clinical studies are underway in the U.S. for depression, Parkinson’s disease and essential tremor.