MARLBOROUGH, Mass.,
Aug. 10, 2021 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) today announced U.S. Food and
Drug Administration (FDA) 510(k) clearance of the EXALT™ Model B
Single-Use Bronchoscope, designed for use in bedside procedures
within the intensive care unit (ICU) and operating room (OR).
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The EXALT Model B Bronchoscope can be used for a wide range of
bronchoscopy procedures such as secretion management, airway
intubation, percutaneous tracheostomy, double lumen endotracheal
tube placement and biopsies. The device is offered in three sizes –
slim, regular and large – each designed to deliver superior suction
performance and direct, precise imaging.
"To effectively diagnose and treat disorders in the lungs and
air passages, physicians require devices that provide high-quality
imaging and visualization into a patient's anatomy," said
Carla R. Lamb, MD, director,
Interventional Pulmonary Medicine and director, Interventional
Pulmonary Fellowship Program, Lahey Hospital & Medical
CenterI. "In my view, this device represents a
scientific advancement in single-use bronchoscopes which could
improve patient care."
Throughout the United States,
more than 1.2 million bedside procedures involving a bronchoscope
are performed in ICU and OR settings each year, and more than 3
million are performed worldwide.II While
infrequent, there have been reports of patient infections linked to
contamination of reprocessed flexible bronchoscopes, even when
device cleaning and disinfection practices aligned with safety
guidelines.III In situations where there is
increased risk of spreading infection or when there is no support
available for immediate reprocessing of a reusable bronchoscope,
the FDA recommends health care providers consider using a
single-use bronchoscope.IV Additionally, when
treating patients with COVID-19, the American Association for
Bronchology & Interventional Pulmonology recommends use of a
single-use bronchoscope when possible.V
"To further increase patient safety and improve operational
efficiencies within the hospital setting, many physicians have been
making the transition to single-use scopes, which eliminate both
the risk of infection associated with reusable devices, as well as
time-intensive scope reprocessing," said Dave Pierce, executive vice president and
president, MedSurg and president, Endoscopy, Boston Scientific.
"Developed with physician needs and varying patient anatomies in
mind, the EXALT Model B Bronchoscope was designed to bring a new
level of suction and imaging performance to single-use scopes and
offers a familiar design and feel to that of a reusable
device."
For decades, Boston Scientific has worked closely with
physicians to develop and introduce single-use technologies to
advance patient care across various therapeutic areas. The EXALT
Model B Bronchoscope is the latest device to join the company's
single-use imaging portfolio alongside the EXALT™ Model D
Single-Use Duodenoscope, LithoVue™ Digital Flexible
Ureteroscope, SpyGlass™ DS Direct Visualization
System and SpyGlass™ Discover Digital Catheter.
The company announced completion of CE Mark for the
EXALT Model B Bronchoscope in May
2021. Limited market release of the device in the U.S. will
begin in the coming weeks.
For more information, please visit the EXALT Model B
Single-Use Bronchoscope page on the Boston Scientific
website.
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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statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
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CONTACTS:
Kirsten Lesak-Greenberg
Media Relations
(763) 300-9254
Kirsten.Lesak-Greenberg@bsci.com
Lauren Tengler
Investor Relations
508-683-4479
BSXInvestorRelations@bsci.com
I Dr. Carla Lamb
is a paid consultant for Boston Scientific Corporation. She has not
been compensated for her quote within this press release.
II 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.
III Mehta A, Muscarella L. Bronchoscope-related
"superbug" infections. CHEST Journal. 2019; 157(2).
DOI: https://doi.org/10.1016/j.chest.2019.08.003
IV U.S. Food & Drug Administration. Flexible
bronchoscopes and updated recommendations for reprocessing: FDA
safety communication. June 25,
2021. https://www.fda.gov/medical-devices/safety-communications/flexible-bronchoscopes-and-updated-recommendations-reprocessing-fda-safety-communication
V Wahidi, Momen M. MD, MBA; Lamb, Carla MD;
Murgu, Septimiu MD; et al. American Association for Bronchology and
Interventional Pulmonology (AABIP) Statement on the Use of
Bronchoscopy and Respiratory Specimen Collection in Patients With
Suspected or Confirmed COVID-19 Infection, Journal of Bronchology
& Interventional Pulmonology: October
2020 - Volume 27 - Issue 4 - p e52-e54 doi:
10.1097/LBR.0000000000000681
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SOURCE Boston Scientific Corporation