Boston Scientific Receives FDA Clearance for EXALT™ Model B Single-Use Bronchoscope

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Aug 10, 2021, 16:00 ET

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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About the EXALT(tm) Model B Single-Use Bronchoscope

Images captured from the scope during procedures are displayed on a high-resolution portable monitor. Images captured from the scope during procedures are displayed on a high-resolution portable monitor.

The EXALT(tm) Model B Single-Use Bronchoscope is offered in three sizes - large, regular and slim.

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 Center^I. "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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^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

SOURCE Boston Scientific Corporation