- Boston Scientific has won FDA 510(k) clearance for a single-use bronchoscope designed to eliminate the infection risk associated with reusable devices.
- FDA has received hundreds of reports about infections or device contamination associated with reusable bronchoscopes in recent years, leading it to advise healthcare providers to consider using single-use products in certain situations.
- Boston Scientific values the market at $2 billion but will face competition from rivals with a longer history in the space, including Ambu and Olympus. A limited market release of the device is set to happen in the U.S. in the coming weeks.
Effective reprocessing of reusable endoscopes after a procedure makes the devices safe for use on other patients. However, the failure to properly maintain an endoscope or reprocess it after use can result in pathogens being transferred between patients via the devices. Bronchoscopes are among the devices identified by FDA as posing a greater risk of microbial transmission.
In June, FDA updated its recommendations in light of 867 reports it received between July 2015 and January 2021. The reports described infections or device contamination associated with reusable flexible bronchoscopes. There were seven reports of deaths. It is unknown if pathogens transferred via the bronchoscopes had a role in the deaths, but a "patient was involved in a multidrug resistant cluster in which a bronchoscope was identified as a commonality."
Boston Scientific, having already brought its EXALT Model D single-use duodenoscope to market, has gained clearance to sell a device that eliminates the cross-contamination risk. The EXALT Model B single-use bronchoscope is a disposable device designed for use in bedside procedures such as secretion management, airway intubation and biopsies in intensive care units and operating rooms.
The U.S. performs more than 1.2 million bedside procedures involving a bronchoscope each year, according to Boston Scientific. FDA created a tailwind for the efforts of manufacturers to convert the procedures to single-use devices in June when it recommended healthcare providers consider using disposable bronchoscopes "where there is increased risk of spreading infection or when there is no support for immediate reprocessing of the bronchoscope."
Boston Scientific sees a sizable opportunity. "We'll launch the bronchoscope in the second half of 2021 and we believe this will be a nice $2 billion market for us," CEO Michael Mahoney told investors on a conference call in February.
Mahoney predicted the bronchoscope will "follow a very similar path ex-COVID as our urology scope did, as well as our Spyglass scope and endo as well." On the same call, Mahoney said the launch of the Spyglass Discover digital catheter, which was cleared in 2020, was going well.
COVID-19 hampered the rollout of the single-use duodenoscope as Boston Scientific's sales teams lacked the physician access needed to support the switch from reusable to disposable devices. The situation has improved somewhat over the past two quarters, with Mahoney describing "an uptick and traction" last month, suggesting EXALT Model B will launch into a more favorable environment.