Boston Scientific receives CE mark for single-use bronchoscope

Boston Scientific has received the 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 variety of bronchoscopy procedures such as secretion management, airway intubation, percutaneous tracheostomy, double lumen endotracheal tube placement and biopsies. 

Prof. Dr. Kaid Darwiche, head of the Department of Interventional Pneumology at Ruhrlandklinik in Germany, said: "As single-use bronchoscopes are relatively new, continued innovation is necessary to ensure physicians can achieve direct and precise visualisation into a patient's lungs and air passages. 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. 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. 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.