Boston Scientific today said it received CE mark approval for its Exalt Model B single-use bronchoscope.
The Marlborough, Mass.–based company designed the device for bedside procedures in the intensive care unit, operating room and bronchoscopy suite.
Exalt Model B is available in three sizes — slim, regular and large — for 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,” Kaid Darwiche, head of the department of interventional pneumology at Ruhrlandklinik in Germany, said in a news release. “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.”
The Exalt Model B bronchoscope is the latest single-use device from Boston Scientific. It follows the Exalt Model D single-use duodenoscope, LithoVue digital flexible ureteroscope, SpyGlass DS direct visualization system and SpyGlass discover digital catheter.
Boston Scientific will launch a limited market release of the Exalt Model B device in Europe in the coming weeks. It is not available for use or sale in the U.S.