Boston Scientific has received U.S. Food and Drug Administration (FDA) 510(k) clearance for 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 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.
Carla R. Lamb, MD, director, Interventional Pulmonary Medicine and director, Interventional Pulmonary Fellowship Program, Lahey Hospital & Medical Centre, said: "To effectively diagnose and treat disorders in the lungs and air passages, physicians require devices that provide high-quality imaging and visualisation into a patient's anatomy. In my view, this device represents a scientific advancement in single-use bronchoscopes which could improve patient care."
In 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. In situations where there is increased risk of spreading infection or when there is no support available for immediate reprocessing of a reusable bronchoscope, the FDA recommends healthcare providers consider using a single-use bronchoscope. Additionally, when treating patients with COVID-19, the American Association for Bronchology & Interventional Pulmonology recommends use of a single-use bronchoscope when possible.
Dave Pierce, executive vice president and president, MedSurg and president, Endoscopy, Boston Scientific, said: “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. 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."
For decades, Boston Scientific has worked closely with physicians to develop and introduce single-use technologies to advance patient care across various therapeutic areas. The EXALT Model B Bronchoscope is the latest device to join the company's single-use imaging portfolio.
The company announced completion of CE Mark for the EXALT Model B Bronchoscope in May 2021. Limited market release of the device in the U.S. will begin in the coming weeks.
