St Jude's Libra deep brain stimulation systems for Parkinson’s
disease gains EU approval
31 January 2009
St Jude Medical, Inc. (NYSE:STJ) has received the European CE Mark
approval for 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 and speech. 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 US 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 US for depression, Parkinson’s disease and essential
tremor.
Bookmark this page