Single-use bronchoscope receives FDA clearance

A new single-use bronchoscope designed by Boston Scientific has received FDA clearance for use in ICU and operating room bedside procedures, according to a press release.

“To further increase patient safety and improve operational efficiencies within the hospital setting, many physicians have been making the transition to single-use scopes, which eliminate both the risk of infection associated with reusable devices, as well as time-intensive scope reprocessing,” Dave A. Pierce, executive vice president and president at MedSurg and president of endoscopy at Boston Scientific, said in the release. “Developed with physician needs and varying patient anatomies in mind, the Exalt Model B bronchoscope was designed to bring a new level of suction and imaging performance to single-use scopes and offers a familiar design and feel to that of a reusable device.”

The Exalt Model B bronchoscope may be beneficial in the field because there have been infrequent reports of infections linked to contamination of reprocessed flexible bronchoscopes, according to the release. In these cases, the FDA recommends the use of a single-use bronchoscope. This device was created for use in various bronchoscopy procedures, including secretion management, airway intubation, percutaneous tracheostomy, double lumen endotracheal tube placement and biopsies.

The single-use bronchoscope comes in slim, regular and large sizes designed to deliver superior suction performance and precise imaging, according to the release.

“To effectively diagnose and treat disorders in the lungs and air passages, physicians require devices that provide high-quality imaging and visualization into a patient's anatomy,” Carla R. Lamb, MD, director of interventional pulmonary medicine and the Interventional Pulmonary Fellowship Program at Lahey Hospital and Medical Center in Burlington, Massachusetts, said in the release. “In my view, this device represents a scientific advancement in single-use bronchoscopes which could improve patient care.”

Boston Scientific has reported CE mark approval for the Exalt Model B bronchoscope in May with a limited U.S. release beginning in the next few weeks.