MARLBOROUGH, Mass.,
April 24, 2018 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) today announced
one-year data from the INTREPID study, the first and only
prospective, double-blind, randomized, sham-controlled,
multi-center study of deep brain stimulation (DBS) for advanced,
levodopa-responsive Parkinson's disease (PD) in the United States. The study is a
late-breaking emerging science session presentation at today's
meeting of the 70th Annual American Academy of Neurology
Meeting in Los Angeles.
The INTREPID study evaluated 292 patients at 23 sites in the
U.S. and successfully met its primary and secondary endpoints. The
data, which supported the recent U.S. FDA approval of the
VERCISETM DBS System for the control of symptoms of PD,
demonstrated the safety and effectiveness of one of the most
innovative additions to the field of DBS in 30 years. DBS is used
to treat the symptoms of PD, a degenerative condition that affects
more than one million people in the U.S. and 10 million
worldwide.1
Highlights of the one-year results include:
- A 49.2 percent improvement in motor symptoms as measured by
clinicians in Unified Parkinson's Disease Rating Scale (UPDRS) III
scores compared to pre-surgery screening;
- A six-hour improvement in on time without troublesome
dyskinesias as measured by a patient-completed three-day PD diary
(motor diary);
- More than 40 percent of stimulation programs used current that
was fractionalized over two or more contacts; and
- An overall sustained improvement in quality of life as measured
by the Parkinson's Disease Questionnaire 39 (PDQ-39).
"This study meets a new level of rigor in evaluating the
effectiveness of a DBS system," said Jerrold Vitek,
M.D., Ph.D, McKnight professor and chair, Department of
Neurology, University of Minnesota
Medical School and coordinating principal investigator
for the INTREPID study. "The double-blind design gives us
confidence that the improvements in patients on time with good
symptom control, as evaluated by the diary data, are an objective
measure of the outcomes and suggests patients will benefit from the
Vercise System."
DBS works by stimulating a targeted region of the brain through
implanted leads that are powered by a device called an implantable
pulse generator. The Vercise System is based on a foundation of
cochlear implant technology and works by allowing the physician to
independently control the amount of current delivered by each of
the eight electrodes on the implanted leads; this proprietary
technology is known as multiple independent current control. The
Vercise System technology is designed to address patient needs and
the progressive nature of the condition with a battery life,
depending on individual use, of more than 15 years and stimulation
that can be adapted as the condition progresses.
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http://parkinson.org/Understanding-Parkinsons/Causes-and-Statistics/Statistics
About Boston Scientific
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CONTACTS
Media:
Catherine
Brady
Media
Relations
508-683-4797
Catherine.Brady@bsci.com
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Investor Relations
Boston Scientific Corporation
BSXInvestorRelations@bsci.com
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