Boston Scientific Receives CE Mark for EXALT™ Model B Single-Use Bronchoscope

MARLBOROUGH, Mass., May 25, 2021 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced that its EXALT™ Model B Single-use Bronchoscope has received CE Mark approval. This single-use device is designed for bedside procedures in the intensive care unit (ICU), the operating room (OR), and the bronchoscopy suite. The device is expected to be available for limited commercial distribution in Europe in the coming weeks.

The EXALT Model B Bronchoscope will be available in three sizes (slim, standard, and large) for use in various bronchoscopic procedures, such as secretion management, endotracheal intubation, percutaneous tracheostomy, double-lumen endotracheal intubation, and biopsy.

Dr. Kaid Darwiche, Professor and Head of Interventional Pulmonology at Germany’s Ruhrlandklinik, stated, “Single-use bronchoscopes are relatively new, making continuous innovation essential to ensure physicians can achieve direct and precise visualization of patients’ lungs and airways. The EXALT Model B Bronchoscope provides clear, well-defined imaging and strong suction capability, both of which are critical for successfully identifying any abnormalities within a patient’s airways.”

Across Europe, over 1.5 million procedures involving bronchoscopy are performed annually.ⁱAlthough the risk of infection due to the reprocessing and reuse of reusable endoscopes is low, there have been reports of endoscope-related contamination and postoperative infections.ⁱⁱTo address this risk, the recently issued position statement by the European Society of Gastrointestinal Endoscopy (ESGE) and the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) strongly recommends the use of disposable endoscopic accessories whenever possible.ⁱⁱⁱ

Dave Pierce, Executive Vice President and President, Surgery and Endoscopy at Boston Scientific, stated, “Single-use endoscopes are increasingly becoming the preferred choice for many physicians, as they eliminate the risk of endoscopy-associated infections caused by inadequate reprocessing, while also improving hospital operational efficiency. Innovation is at the core of our mission, and the EXALT Model B Bronchoscope is designed to deliver high-quality performance and the same handling experience as reusable endoscopes, while meeting heightened patient safety requirements and enhancing efficiency.”

The EXALT Model B Bronchoscope is the latest device in Boston Scientific's 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, urologic, and airway spaces to advance patient care, includingEXALT™ Model D Single-Use Duodenoscope、LithoVue™ Digital Flexible Ureteroscope、SpyGlass™ DS Direct Visualization SystemandSpyGlass™ Discover Digital Catheter.

Please visitwww.bostonscientific.eu/EXALT-BLearn more about the EXALT Model B Bronchoscope.

The EXALT Model B Bronchoscope is not available for use or sale in the United States.

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Boston Scientific is dedicated to innovating medical solutions to improve the lives of patients worldwide. For more than 40 years, Boston Scientific has led the global medical technology industry by providing a broad range of high-performance medical solutions that address unmet patient needs and reduce healthcare costs. For more information, please visitwww.bostonscientific.com, and can beTwitterandFacebookContact.

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Media Relations, Europe, Middle East, Africa
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Media Relations, United States
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Investor Relations
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ⁱ Boston Scientific Corporation archived data. Market research as of 2019, including projections for 2020, which incorporates estimates of 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