EXALT™ Model B

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

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MARLBOROUGH, Mass., August 10, 2021 -- 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).

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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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