FDA clears Boston Scientific’s Exalt Model B single-use bronchoscope

Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its Exalt Model B single-use bronchoscope.

Marlborough, Mass.-based Boston Scientific designed the Exalt Model B for use in bedside procedures within the intensive care unit and operating room, according to a news release. Uses for the device include a wide range of bronchoscopy procedures, including secretion management, airway intubation, percutaneous tracheostomy, double-lumen endotracheal tube placement and biopsies.

According to a news release, Boston Scientific offers the device in three sizes — slim, regular and large — with each sizing designed to offer superior suction performance and direct, precise imaging.

Exalt Model B joins the Exalt Model D single-use duodenoscope, the LithoVue digital flexible ureteroscope, the SpyGlass DS direct visualization system and the SpyGlass Discover digital catheter. Exalt Model B received CE mark approval in May and Boston Scientific plans to begin the limited market release of the platform in the U.S. within the coming weeks.

“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,” Boston Scientific EVP, president of medsurg & president of endoscopy Dave Pierce 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.”

Original Article: (https://www.massdevice.com/fda-clears-boston-scientifics-exalt-model-b-single-use-bronchoscope/)