FDA Approves Optiguide Flexible Fiber
Pinnacle Biologics was granted U.S. Food and Drug Administration premarket supplemental approval for its Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber.
Courtesy of Concordia Healthcare Corp.
Used in the treatment of non-small-cell lung and esophageal cancer, the device features a flexible, narrow cylindrical diffuser design that may give physicians greater access to tumors in the right upper lobe of the lung. It also improves maneuverability in other potentially challenging anatomic areas of the bronchus.
In January, the company reached an agreement with the FDA under a special protocol assessment to enroll patients with an advanced form of bile-duct cancer in a pivotal Phase 3 clinical trial, a cancer type for which there is currently no approved therapy.