Boston Scientific Completes CE Mark for EXALT™ Model B Single-Use Bronchoscope
MARLBOROUGH, Mass., May 25, 2021
Company to begin limited market release in Europe in June
MARLBOROUGH, Mass., May 25, 2021 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has completed CE Mark for the EXALT™ 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.
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™ Model D Single-Use Duodenoscope, LithoVue™ Digital Flexible Ureteroscope, SpyGlass™ DS Direct Visualization System and SpyGlass™ 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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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
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SOURCE Boston Scientific Corporation