Olympus Announces Pediatric Use Indication for Two Single-Use Bronchoscopes
The H-SteriScope™ single-use video flexible bronchoscopes are manufactured by Hunan Vathin® Medical Instrument Co., Ltd., and distributed exclusively by Olympus America Inc. The FDA granted Vathin Medical 510(k) clearance of a pediatric use indication for:
- Zero BCV1-02 model bronchoscope with a 2.2mm distal end approved for pediatric use in ages 6 months to 6 years
- Slim BCV1-C2 model bronchoscope with a 3.2mm distal end and a 1.2mm working channel approved for pediatric use in ages 6 years and older.
The bronchoscopes indicated for pediatric use are now available.
"Patient safety and proper diagnoses are paramount, so it's critical that physicians have access to medical devices that meet the specific needs of pediatric patients." said Dr.
Differentiating features of the H-SteriScopes™ that are useful in respiratory care include 90° rotation left and right, 210° angulation up and down and passive bending for enhanced maneuverability.
H-SteriScopes™ are compatible with the DVM-B2 Digital Video Monitor, also manufactured by Vathin Medical® Instrument Co., Ltd., and distributed exclusively by Olympus America Inc. The portable 12.1-inch monitor allows for ease of care in critical or emergent situations as it can be attached bedside to an IV pole or mounted on a nearby cart.
"Olympus is very pleased to announce the pediatric indication for the Zero and Slim H-Steriscope bronchoscopes. Patient focus is at the core of everything we do as Olympus strives to provide physicians with the tools they need to help improve patient outcomes," said
Complications from bronchoscopy are rare and most often minor, but if they occur, may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications. Some patients may experience rare but more serious complications such as a collapsed lung, respiratory failure, heart attack, and/or cardiac arrhythmia.
For information about the complete Olympus pulmonology portfolio, please visit the pulmonology product page.
About Olympus
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in
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SOURCE Olympus Corporation of the Americas
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