St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced regulatory and reimbursement approval from the
Australian Therapeutic Goods Administration (TGA) of its Brio™
deep brain stimulation (DBS) system for treating the symptoms
of Parkinson’s disease.
“Because we recognize that some patients are
better served by rechargeable systems and others with non-rechargeable
systems, we are pleased to provide physicians with options that allow
them to customize systems to match the patient’s needs.”
The Brio
neurostimulator is the world’s smallest, longest-lasting
rechargeable DBS system. Featuring a thin 10 mm profile, the device
is slightly larger than the typical man’s watch and weighs 29 grams
(approximately 1 oz). In addition to its small size, the Brio
neurostimulator has a 10-year battery life approval -- the longest of
any rechargeable DBS device currently on the market.
In addition to the regulatory and reimbursement approval of the Brio DBS
system, reimbursement authorization was granted for the Libra™
and LibraXP™ non-rechargeable DBS systems, which
had received prior TGA approval in 2009.
“The approval of the Brio DBS system in Australia is an exciting
addition to our product line that includes the Libra and LibraXP
neurostimulators,” said Chris Chavez, president of the St. Jude Medical
Neuromodulation Division. “Because we recognize that some patients are
better served by rechargeable systems and others with non-rechargeable
systems, we are pleased to provide physicians with options that allow
them to customize systems to match the patient’s needs.”
The Brio neurostimulator has the greatest implant depth of any
rechargeable DBS device available today. The implant depth combined with
the device’s thin profile potentially make it less noticeable and more
comfortable for patients, while providing physicians with flexibility in
selecting the implant location. Additionally, the device is designed
with a battery that should provide sustainable therapy while maintaining
a reasonable recharge interval for at least 10 years of use at high
settings. The device’s battery longevity may also maximize the time
between device replacement procedures.
The Brio neurostimulator also features: