MARLBOROUGH, Mass.,
Sept. 30, 2020 /PRNewswire/
-- Boston Scientific (NYSE: BSX) today announced the European
launch of the WaveWriter Alpha™ portfolio of Spinal Cord Stimulator
(SCS) Systems. The portfolio, consisting of four MRI
conditionali, Bluetooth-enabled implantable pulse
generators (IPGs), offers expanded personalization based on patient
needs, including rechargeable and non-rechargeable options, and
access to waveforms that can cover multiple areas of pain.
Chronic pain, defined as continuous and long-term pain lasting
more than 12 weeks, impacts approximately 100 million people across
Europe.ii,iii SCS
therapies provide pain relief by delivering pulses of mild electric
current to the spinal cord to interrupt pain signals traveling to
the brain. The WaveWriter Alpha SCS Systems received CE Mark and
are indicated as an aid in the management of chronic intractable
pain. It is also indicated for peripheral nerve stimulation of the
trunk for pain management.
The systems feature combination therapy, the only SCS portfolio
that has the ability to layer paraesthesia and paraesthesia-free
options simultaneously, and support up to 32 contacts that
target specific nerves along the spinal cord to meet the personal
pain relief coverage needs of the individual patient. The
Bluetooth platform enables faster programming that can be done
while maintaining a typical physical distance of 10 feet (3meters)
between the programmer and the patient.
"Being able to offer my patients different therapy options is
important because it provides them with pain relief that can
maintain long-term results," said Jan
Vesper, M.D. Ph.D., Department of Functional Neurosurgery
and Stereotaxy at the University Hospital of Düsseldorf,
Germany. "The combination of
different therapy features that promote simplicity like the
WaveWriter Alpha SCS Systems enable enhanced personalization in the
advanced treatment of chronic pain."
The COMBO randomized control trial, which compared the
effectiveness of SCS with multiple modalities to conventional SCS
in patients with chronic pain, found 88% of patients were
responders with multiple modalities, which is defined as patients
achieving 50% or greater pain relief compared to baseline. Patients
also realized a significant 26-point improvement in functional
disabilityiv where many patients who were
"severely" or "moderately disabled" were able to return to many of
their daily activities.v Multiple Level 1 RCTs and
real-world studies support the design of Boston Scientific's SCS
therapy.vi,vii,viii,ix,x
"Chronic pain can severely impact a patient's ability to carry
out daily activities," said Jan Willem
Kallewaard, M.D., Rijnstate Hospital, Arnhem, The Netherlands. "With the WaveWriter
Alpha SCS Systems, not only are patients likely to achieve a
successful outcome, but their quality of life is also being
dramatically improved by regaining many functional abilities."
"The launch of the WaveWriter Alpha SCS Systems in Europe represent a significant step forward in
the treatment of chronic pain," said Maulik
Nanavaty, senior vice president and president,
Neuromodulation, Boston Scientific. "By unifying our portfolio of
SCS devices and offering the latest therapy advances, we remain
committed to advancing meaningful innovation, providing both
physicians and patients access to the full benefits of our entire
portfolio of devices."
The WaveWriter Alpha SCS Systems are not available for use or sale
in the United States.
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 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
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 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;
intellectual property; litigation; financial market conditions; and
future business decisions made by us and our competitors. All
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
any change in our expectations or in events, conditions or
circumstances on which those expectations may be based, or that may
affect the likelihood that actual results will differ from those
contained in the forward-looking statements. This cautionary
statement is applicable to all forward-looking statements contained
in this document.
CONTACTS:
Rainer Puster
Media Relations, Europe
+491754347057
Rainer.Puster@bsci.com
Rochelle Silsbee
Media Relations, U.S.
+1 (818) 812-7320 (office)
Rochelle.Silsbee@bsci.com
Susie Lisa, CFA
Investor Relations
+1 (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 Mills S et al. Identification and Management of
Chronic Pain in Primary Care: A Review of Current Psychiatry
Reports. 2016.
iii Policy Connect. About Chronic Pain.
https://www.policyconnect.org.uk/cppc/about-chronic-pain Accessed
March 2012
iv Oswestry Disability Index
v Wallace M et al. Outcomes of a Prospective
Randomized Controlled Trial Utilizing a Spinal Cord
System Capable of Multiple Neurostimulative Modalities (COMBO).
NANS Annual Meeting. January
2020.
vi Thomson, Simon et al. Effects of Rate on
Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results
of the PROCO Randomized Controlled Trial. Neuromodulation,
January 2018.
vii North J et al. Outcomes of a Multicenter,
Prospective, Crossover, Randomized Controlled Trial Evaluating
Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously
Implanted Subjects. Neuromodulation. January
2020.
viii Metzger C et al. Pain Relief Outcomes Using an
SCS Device Capable of Delivering Combination Therapy with Advanced
Waveforms and Field Shapes. Expert Rev Med Devices. September 2020.
ix Veizi E et al. Spinal Cord Stimulation
(SCS) with Anatomically Guided (3D) Neural Targeting Shows Superior
Chronic Axial Low Back Pain Relief Compared to Traditional
SCS-LUMINA Study. Pain Med. November
2018.
x Paz et al. HALO Study: Exploration of High and
Low Frequency Outcomes in Sub-p (n=30), INS 2019
View original content to download
multimedia:http://www.prnewswire.com/news-releases/boston-scientific-launches-wavewriter-alpha-spinal-cord-stimulator-systems-in-europe-301142288.html
SOURCE Boston Scientific Corporation