Boston Scientific has obtained CE mark for its EXALT Model B Single-Use Bronchoscope, a device meant for bedside procedures in the intensive care unit, operating room and bronchoscopy suite.
The company plans to introduce the bronchoscope soon, with a limited launch in Europe.
Designed especially for patients and procedures, EXALT Model B is equipped with suction and imaging capabilities.
The device will be marketed 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.
Boston Scientific endoscopy president Dave Pierce said: “Single-use scopes are emerging as the preference for many physicians due to their ability to eliminate the risk of scope-related infection that may result from ineffective reprocessing while also increasing operational efficiencies in the hospital setting.
“Innovation is central to our mission, and the EXALT Model B Bronchoscope is designed to provide physicians with the high-quality functionality and feel of a reusable scope while addressing heightened patient safety needs and improving efficiency.”
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The latest asset in Boston Scientific’s single-use imaging portfolio, the bronchoscope is currently not offered in the US.
The company noted that approximately 1.5 million bronchoscope-based procedures are carried out in Europe every year.
Even though reprocessed reusable scopes are associated with a low risk of infection, some scope-related contaminations and post-procedure infections have been reported.
To fight this risk, the European Society of Gastrointestinal Endoscopy and the European Society of Gastroenterology Nurses and Associates advise the usage of single-use endoscopic accessories if possible.
Last month, Boston Scientific reported net sales of $2.752bn in the first quarter, representing a growth of 8.2% on a reported basis, compared to $2.543bn in the same quarter last year.