FDA OKs Pediatric Use for 2 Single-Use Bronchoscopes

Olympus Corp. of the Americas announced that the U.S. Food and Drug Administration (FDA) cleared a pediatric use indication for two single-use bronchoscopes in the respiratory portfolio it distributes.

Hunan Vathin’s H-SteriScope single-use video flexible bronchoscopes are distributed exclusively by Olympus. The FDA awarded 510(k) clearance for the Zero BCV1-02 model bronchoscope with a 2.2 mm distal end (ages six months to six years) and Slim BCV1-C2 model bronchoscope with a 3.2mm distal end and a 1.2mm working channel (ages six years and older).

The H-SteriScopes feature 90-degree rotation left and right, 210-degree angulation up and down, and passive bending.

“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. Erik Hysinger, a pediatric pulmonologist at Cincinnati Children’s Hospital. “This is particularly important in infants where airway size is dramatically smaller than in adult patients. These bronchoscopes provide the optics and maneuverability critical for making the best diagnosis, while simultaneously being small enough to support the unique physiology of pediatric patients.”

The scopes are compatible with the DVM-B2 digital video monitor, which is also made by Vathin and exclusively distributed by Olympus. The portable 12.1-inch monitor can be attached bedside to an IV pole or mounted on a nearby cart for ease of use in critical or emergent situations.

“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 Jeff Schmitt, senior VP and general manager of Respiratory at Olympus. “Olympus’ bronchoscopy portfolio offers the right scope for the right patient in the right situation.”

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