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FDA grants premarket supplemental approval for Optiguide flexible fiber
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Concordia Healthcare Corp. today announced that its subsidiary Pinnacle Biologics, Inc. was granted FDA premarket supplemental approval for the redesigned flexible fiber of its photodynamic therapy system, used in the treatment of non-small cell lung cancer and esophageal cancer.
The Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber features a more malleable, narrower cylindrical diffuser design that could assist physicians by providing greater access to tumors located in the right upper lobe of the lung and could improve maneuverability in potentially challenging anatomic areas of the bronchus.
“One of the key benefits of this new diffuser fiber is that it will offer improved compatibility with current endoscopic equipment,” Patrick Ross MD, PhD, chairman of the Pinnacle Scientific Advisory Board, said in a press release. “This may allow doctors to use bronchoscopes with smaller therapeutic channels and may allow easier access to NSCLC tumors located in the right upper lobe of the lung as well as other potentially challenging anatomic areas of the airways in the lungs.”
The company announced in early January it has reached an agreement with the FDA under a special protocol assessment to enroll patients with an advanced form of bile duct cancer – for which there is currently no approved therapy – in a pivotal phase 3 clinical trial.
“Pinnacle has continued to aggressively advance photodynamic technology, design and materials in furtherance of its mission to expand and improve treatment options for critically ill patients with rare diseases like lung and esophageal cancers,” said Mark Thompson, CEO of Concordia. “We are pleased that this newly approved Optiguide DCYL700 Fiber Optic Diffuser Series device will give physicians a new and important tool in their [photodynamic therapy] armamentarium.”