MARLBOROUGH, Mass.,
Jan. 14, 2021 /PRNewswire/ -- Boston
Scientific (NYSE: BSX) has announced a limited market release of
the WaveWriter Alpha™ portfolio of Spinal Cord
Stimulator (SCS) systems. The unified portfolio of four MRI
conditional, Bluetooth-enabled rechargeable and non-rechargeable
implantable pulse generators (IPGs) provides uncompromised
personalization, and for the first time in SCS, Fast Acting
Sub-perception Therapy (FAST™) designed to deliver
profound paresthesia-free pain relief in
minutes.i The systems are supported by
the Cognita™ Solutions suite of digital tools for
patients and physicians.
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Chronic pain, defined as continuous and long-term pain lasting
more than six months, impacts more than 50 million people in the
U.S. with 19.6 million adults experiencing high-impact chronic pain
that interferes with daily life or work
activities.ii SCS therapies provide pain relief by
sending mild electric pulses to the spinal cord to interrupt pain
signals traveling to the brain. Paresthesia-based therapy provides
pain relief with a light tingling sensation while paresthesia-free
therapy works without that sensation.
Traditional paresthesia-free therapy can take up to a few days
or longer to provide pain relief. Boston Scientific's proprietary
FAST therapy is designed to provide immediate paresthesia-free pain
relief by targeting a new and distinct SCS mechanism of action
revealed through a multi-year research collaboration with Duke
University.
"We have found that the specific targeting and stimulation
parameters of FAST uniquely engage the surround inhibition
mechanism to produce rapid and robust pain relief," commented
Warren M. Grill, distinguished
professor of biomedical engineering, Duke
University. "What sets FAST apart from other forms of SCS is
that we understand the underlying mechanism, which helps define
clinical practices to optimize patient outcomes."
The WaveWriter Alpha SCS Systems are supported by Cognita
Solutions to address common challenges in pain management,
including raising awareness about drug-free pain management
options, helping patients find local physicians, and helping
physicians sustain functional outcomes for patients over the
long-term.
"It is with great enthusiasm that we embark on the next era of
personalization with the WaveWriter Alpha SCS Systems," said
Maulik Nanavaty, senior vice
president and president, Neuromodulation, Boston Scientific.
"Combined with our family of innovative and proven solutions for
the treatment of chronic pain, including the
Vertiflex™ Procedure and radiofrequency ablation, we
are helping physicians provide treatments that span the continuum
of care so patients can find access to the medical support they
need to live better lives."
The WaveWriter Alpha SCS Systems were approved by the U.S. Food
and Drug Administration in December
2020 and is indicated as an aid in the management of chronic
intractable pain of the trunk and/or limbs including unilateral or
bilateral pain associated with failed back surgery syndrome,
Complex Regional Pain Syndrome Types I and II, intractable low back
pain and leg pain.
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 40 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
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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 our business plans 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
business strategy and may cause actual results to differ materially
from those contemplated by the statements expressed in this press
release. As a result, readers are cautioned not to place
undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other
things: future economic, competitive, reimbursement and regulatory
conditions; new product introductions; demographic trends;
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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
uncertainties that may affect our future operations, see Part I,
Item 1A – Risk Factors in our most recent Annual Report on
Form 10-K filed with the Securities and Exchange Commission, which
we may update in Part II, Item 1A – Risk Factors in
Quarterly Reports on Form 10-Q we have filed or will file
hereafter. We disclaim any intention or obligation to
publicly update or revise any forward-looking statements to reflect
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statement is applicable to all forward-looking statements contained
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CONTACTS:
Rochelle Silsbee
Media Relations
(818) 812-7320 (office)
Rochelle.Silsbee@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
i The WaveWriter Alpha™ and WaveWriter
Alpha™ Prime Spinal Cord Stimulator Systems provide
safe access to full-body 1.5T MRI scans when used with specific
components and exposed to the MRI environment under the defined
conditions in the ImageReady™ MRI Full Body Guidelines
for WaveWriter Alpha™ and WaveWriter
Alpha™ Prime Spinal Cord Stimulator Systems
ii U.S. Department of Health and Human Services
(2019, May). Pain Management Best Practices Inter-Agency Task Force
Report: Updates, Gaps, Inconsistencies, and Recommendations.
Retrieved from U. S. Department of Health and Human Services
website:
https://www.hhs.gov/ash/advisory-committees/pain/reports/index.html
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SOURCE Boston Scientific Corporation