MARLBOROUGH, Mass.,
March 17, 2015 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) has received FDA
and CE Mark approval of the EMBLEM™ Subcutaneous Implantable
Defibrillator (S-ICD) System. The EMBLEM S-ICD System is a
treatment option that provides protection for patients at risk of
sudden cardiac arrest (SCA), yet leaves the heart and vasculature
untouched, minimizing the risk of complications associated with
conventional transvenous implantable cardioverter-defibrillators
(TV-ICDs). A controlled and limited market release has begun in a
small number of European centers with a broad European launch
scheduled for May 2015 and subsequent
U.S. launch planned for the third quarter of 2015.
"We are excited to offer the second generation S-ICD System to
physicians as a compelling treatment option for the majority of
ICD-indicated patients," said Kenneth
Stein, M.D., Chief Medical Officer, Rhythm Management,
Boston Scientific. "With the already established robust safety and
efficacy clinical data, the EMBLEM S-ICD System is designed to
enhance patient comfort, while still providing a less invasive
treatment for patients at risk of cardiac arrest."
Unlike traditional ICDs that require placement of at least one
lead in or on the heart, the S-ICD System is implanted just under
the skin and provides the patient the same protection from cardiac
arrest without invading the heart and blood vessels. Leads in
the heart may be associated with infrequent but serious
complications, including lead displacement, fracture and systemic
blood infections, or the need for lead extraction, which may lead
to hospital readmission, increased mortality and associated
costs.
The new generation EMBLEM S-ICD System is 19% thinner and is
projected to last 40% longer than the previous S-ICD System. These
improvements will further improve patient comfort and cosmetic
outcomes while reducing the number of times the device will require
replacement. The EMBLEM S-ICD System is also enabled for remote
patient management through the LATITUDE™ NXT Patient Management
System for increased patient convenience.
"We are further strengthening our range of therapeutic solutions
to protect patients from sudden cardiac arrest," said Joe Fitzgerald, executive vice president and
president of Rhythm Management at Boston Scientific. "Boston
Scientific is the first and only company to offer a fully
subcutaneous ICD, and we expect to maintain leadership in this
category through continued investment in technology and clinical
science. We are very pleased with this earlier than expected FDA
approval, and will immediately begin preparations for a mid-year
launch of the EMBLEM device in the US."
For more information on the S-ICD System visit
www.sicdsystem.com.
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 us
at www.bostonscientific.com. For more information, visit us
at www.bostonscientific.com or connect with us on Twitter or
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 new product launches and launch cadence, regulatory
approvals, clinical trials, product performance and competitive
offerings. 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
Media:
Trish
Backes
651-582-5887 (office)
612-296-8067 (cell)
Media Relations
Boston Scientific Corporation
Trish.backes@bsci.com
Investors:
Susie Lisa,
CFA
508-683-5565 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/boston-scientific-announces-fda-and-ce-mark-approval-of-the-emblem-s-icd-system-300051944.html
SOURCE Boston Scientific Corporation