MARLBOROUGH, Mass.,
April 16, 2015 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) is taking a new
approach to evaluate the performance of the Vessix™ Renal
Denervation System, initiating a study with a novel design to
isolate the effects of the therapy in patients with high blood
pressure, a silent cardiovascular killer affecting millions of
people worldwide.
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The first patient in the REDUCE-HTN: REINFORCE study was
enrolled this week at Cardiology P.C. at Princeton Baptist Medical
Center in Birmingham, Ala. by
Farrell Mendelsohn, M.D., site principal investigator, and referred
by Michael Wilensky, M.D.
Boston Scientific received an investigational device
exemption (IDE) for the study from the Food & Drug
Administration (FDA) in December.
REDUCE-HTN: REINFORCE is a randomized, sham-controlled,
multicenter study designed to isolate and demonstrate the effects
of the Vessix™ Renal Denervation System by minimizing variability
and factors that may have affected results in a competitive
technology trial last year. Similar to pharmaceutical early
effectiveness studies, patients in the study will undergo a
four-week washout period prior to enrollment in which they will
stop taking all hypertension medications.
"Patients with hypertension need a better therapy and we believe
this study design will help us to understand better the clinical
value of renal denervation," said Martin
Leon, M.D., co-principal investigator and director, Center
for Interventional Vascular Therapy at Columbia
University Medical Center / New York-Presbyterian Hospital,
New York City.
The REDUCE-HTN: REINFORCE study will enroll 100 patients. The
primary efficacy assessment is the mean reduction in average
24-hour ambulatory systolic blood pressure (ASBP) at eight weeks
post randomization. First results may be obtained in the first half
of 2016.
"Previous results of renal denervation studies have been
affected by a focus on patients with the difficult-to-define
condition of treatment-resistant hypertension, made even more
complex by uncertainties regarding their use of hypertension
medications," said Michael Weber,
M.D., co-principal investigator and professor of medicine, SUNY
Downstate College of Medicine, Brooklyn,
NY. "We need to find clarity, and we believe this innovative
study design will enable us to do so."
The Vessix System is a differentiated and advanced renal
denervation system using a multi-electrode bipolar catheter
designed to reduce procedural variability. It features a
30-second treatment time and an over-the-wire, balloon-based
approach familiar to most cardiac and vascular specialists. The
Vessix System has both CE Mark and Australian Government,
Therapeutic Goods Administration (TGA) approval and is available
for sale in Europe, the
Middle East, Australia, New
Zealand and select markets in Asia. The Vessix System is an investigational
device and not available for sale in the
United States.
"We believe the Vessix System is a meaningful innovation to help
advance the care of patients with hypertension," said Jeff Mirviss, president, Peripheral
Interventions, Boston Scientific. "That is why we worked with the
broader hypertension clinical community to develop a unique and
comprehensive study that will provide critical data to inform the
field and demonstrate the true effect of renal denervation in
reducing high blood pressure."
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the
world. As a global medical technology leader for more than 35
years, we advance science for life by providing a broad range of
high performance solutions that address unmet patient needs and
reduce the cost of healthcare. For more information, visit
www.bostonscientific.com and connect on Twitter and Facebook.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements may be identified by words like
"anticipate," "expect," "project," "believe," "plan," "estimate,"
"intend" and similar words. These forward-looking statements
are based on our beliefs, assumptions and estimates using
information available to us at the time and are not intended to be
guarantees of future events or performance. These
forward-looking statements include, among other things, statements
regarding the REDUCE-HTN: REINFORCE study, regulatory approvals,
clinical trials and impact of data, and product performance and
impact. If our underlying assumptions turn out to be
incorrect, or if certain risks or uncertainties materialize, actual
results could vary materially from the expectations and projections
expressed or implied by our forward-looking statements. These
factors, in some cases, have affected and in the future (together
with other factors) could affect our ability to implement our
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of these factors are difficult or impossible to predict accurately
and many of them are beyond our control. For a further list
and description of these and other important risks and
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Item 1A – Risk Factors in our most recent Annual Report on
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we may update in Part II, Item 1A – Risk Factors in
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CONTACTS
Media: Ryan Davenport
Global Media Relations
Boston Scientific Corporation
763-494-2664 (office)
media@bsci.com
Investors: Susie Lisa,
CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific Corporation