Boston Scientific Corporation 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.
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. 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.
