Boston Scientific Completes CE Mark for EXALT(TM) Model B Single-Use Bronchoscope
PR89702
MARLBOROUGH, Mass., May 25, 2021 /PRNewswire=KYODO JBN/ --
-- Company to begin limited market release in Europe in June
Boston Scientific Corporation (NYSE: BSX) today announced it has completed CE
Mark for the EXALT(TM) Model B Single-Use Bronchoscope, a single-use device
designed for bedside procedures in the intensive care unit, operating room and
bronchoscopy suite. Limited market release of the device is expected to
commence in Europe in the coming weeks.
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The EXALT Model B Bronchoscope will be offered in three sizes - slim, regular
and large - to allow for use in a wide variety of bronchoscopy procedures such
as secretion management, airway intubation, percutaneous tracheostomy, double
lumen endotracheal tube placement and biopsies.
"As single-use bronchoscopes are relatively new, continued innovation is
necessary to ensure physicians can achieve direct and precise visualization
into a patient's lungs and air passages," said Prof. Dr. Kaid Darwiche, head of
the Department of Interventional Pneumology at Ruhrlandklinik in Germany. "The
EXALT Model B Bronchoscope provides clear, crisp imaging and high-powered
suction - both of which are critical to successfully identify any abnormalities
in the patient's airway."
Throughout Europe, more than 1.5 million procedures involving a bronchoscope
are performed each year.(i) While the potential for infection due to
reprocessing of reusable scopes is low, there have been reports of
scope-associated contaminations and post-procedure infections.(ii) To combat
this risk, a recent position statement from the European Society of
Gastrointestinal Endoscopy (ESGE) and the European Society of Gastroenterology
Nurses and Associates (ESGENA) strongly recommended the use of single-use
endoscopic accessories whenever possible.(iii)
"Single-use scopes are emerging as the preference for many physicians due to
their ability to eliminate the risk of scope-related infection that may result
from ineffective reprocessing while also increasing operational efficiencies in
the hospital setting," said Dave Pierce, executive vice president and president
of MedSurg and president of Endoscopy, Boston Scientific. "Innovation is
central to our mission, and the EXALT Model B Bronchoscope is designed to
provide physicians with the high-quality functionality and feel of a reusable
scope, while addressing heightened patient safety needs and improving
efficiency."
The EXALT Model B Bronchoscope is the latest device in the Boston Scientific
single-use imaging portfolio. For decades, the company has worked closely with
physicians to continuously innovate and develop single-use technologies within
the gastrointestinal, pancreaticobiliary, surgical, urological and airway
spaces to advance patient care, including the EXALT(TM) Model D Single-Use
Duodenoscope (
), LithoVue(TM) Digital Flexible Ureteroscope (
), SpyGlass(TM) DS Direct Visualization System (
) and SpyGlass(TM) Discover Digital Catheter (
).
Please visit
www.bostonscientific.com/en-EU/medical-specialties/pulmonology/EXALT-B.html for
more information about the EXALT Model B Bronchoscope.
The EXALT Model B Bronchoscope is 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 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 (
).
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CONTACTS:
Francesca Cardarelli
Media Relations, EMEA
+39 340 662 6364
Francesca.Cardarelli@bsci.com
Kirsten Lesak-Greenberg
Media Relations, U.S.
+1 (763) 300-9254
Kirsten.Lesak-Greenberg@bsci.com
Susie Lisa, CFA
Investor Relations
+1 (508) 683-5670
BSXInvestorRelations@bsci.com
(i) Data on file at Boston Scientific Corporation. Market research is as of
2019 and includes projections for 2020, incorporating estimates for the
COVID-19 pandemic.
(ii) Mehta A, Muscarella L. Bronchoscope-related "superbug" infections. CHEST
Journal. 2019; 157(2). DOI:https://doi.org/10.1016/j.chest.2019.08.003
(iii) Beilenhoff Ulrike et al. Reprocessing in GI endoscopy: ESGE-ESGENA
Position Statement - Update 2018, Endoscopy 2018; 50
SOURCE: Boston Scientific Corporation
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