MARLBOROUGH, Mass.,
June 29, 2020 /PRNewswire/
-- Boston Scientific (NYSE: BSX) has received U.S. Food and
Drug Administration (FDA) 510(k) clearance for the LUX-Dx™
Insertable Cardiac Monitor (ICM) System, a new, long-term
diagnostic device implanted in patients to detect arrhythmias
associated with conditions such as atrial fibrillation (AF),
cryptogenic stroke and syncope.
The new LUX-Dx ICM System is designed with a dual-stage
algorithm that detects and then verifies potential arrhythmias
before an alert is sent to clinicians, thereby providing actionable
data for clinical decision-making. Further, the remote programming
capabilities of the device via the LATITUDE Clarity™ Data
Management System website allow physicians and care teams to adjust
event detection settings without requiring an in-person patient
appointment, a feature unavailable on any other ICM currently on
the market.
"For physicians, receiving accurate monitoring data and having
remote access to programming provides the opportunity to operate
with more efficiency and confidence," said Kenneth Stein, M.D., senior vice president and
chief medical officer, Rhythm Management and Global Health Policy,
Boston Scientific. "The LUX-Dx ICM System is designed to provide
physicians the ability to accelerate critical clinical decisions
and allow them to spend more time focusing on patient outcomes by
reviewing monitoring data and catching false positive detections
without compromising sensitivity."
The dual-stage algorithm within the LUX-Dx ICM System can be
programmed to identify AF, atrial flutter, rhythm pause,
bradycardia and tachycardia episodes and allows the device to
detect arrhythmias each time established thresholds or parameters
are exceeded. An additional level of verification filters is then
applied, which was developed to catch false positive detections
before an alert is sent. Additionally, after implant, patients are
provided with a mobile device preloaded with the MyLUX™ app which
connects via Bluetooth® to their ICM device. The app
transmits device data daily, or as needed, to the LATITUDE Clarity
Data Management System giving physicians and care teams timely
access to vital information.
"The LUX-Dx ICM System represents a significant step forward in
developing the diagnostic portfolio for Boston Scientific," said
Scott Olson, senior vice president
and president, Rhythm Management, Boston Scientific. "The addition
of this new offering, alongside existing products and services,
affirms our commitment to providing meaningful innovations for the
detection and treatment of patients with cardiac arrhythmias."
The company will immediately begin a limited market release of
the LUX-Dx ICM System in the U.S. with full launch of the product
commencing later this year.
Please visit our Electrophysiology Specialties page to learn
more about our products.
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:
Steve Bailey
Media Relations
(651) 582-4343 (office)
Steve.Bailey@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/boston-scientific-receives-fda-510k-clearance-for-the-lux-dx-insertable-cardiac-monitor-system-301084480.html
SOURCE Boston Scientific Corporation