The US Food and Drug Administration (FDA) has granted 510(k) clearance to Boston Scientific’s EXALT Model B Single-Use Bronchoscope for use in bedside procedures in intensive care units (ICU) and operating rooms (OR).
The device is equipped with high suction as well as imaging capabilities.
It is available in slim, regular and large sizes to enable various bronchoscopy procedures, including secretion management, airway intubation, percutaneous tracheostomy, double-lumen endotracheal tube placement and biopsies.
With FDA approval secured, the device will soon be launched on a limited basis in the US.
Boston Scientific Endoscopy president and MedSurg executive vice-president and president Dave Pierce 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.”
In May, the EXALT Model B Bronchoscope received CE mark for use in ICU and OR settings.
The bronchoscope is the latest addition to Boston Scientific’s portfolio of single-use imaging devices, which includes the EXALT Model D Single-Use Duodenoscope, LithoVue Digital Flexible Ureteroscope, SpyGlass DS Direct Visualization System and SpyGlass Discover Digital Catheter.
Boston Scientific noted that more than 1.2 million bronchoscope-based bedside procedures are carried out in ICU and OR settings in the US every year.
Reports show that, although uncommon, reprocessed flexible scopes are associated with some cases of patient infections due to device contamination, the company added.
To fight the high risk of infection spread, or when a reusable bronchoscope cannot be reprocessed instantly, the FDA recommends the use of a single-use bronchoscope.
Furthermore, the American Association for Bronchology and Interventional Pulmonology advises the use of a single-use bronchoscope for treating Covid-19 patients, when possible.