Privately held medical technology company Polyganics, which develops, manufactures and commercialises bioresorbable medical devices, has announced that the US Food and Drug Administration (FDA) has granted its request for Breakthrough Device designation for its Liver and Pancreas Sealant Patch.
A Breakthough Device is a device that may prevent or treat a life-threatening or irreversibly debilitating disease or condition. Under the Breakthrough Devices programme, the FDA will provide its support to advance the Liver and Pancreas Sealant Patch from development to marketing decision.
The Patch is considered a unique breakthrough in the prevention of fluid leakage after hepato-pancreato-biliary (HPB) procedures, for which no approved or cleared alternatives currently exist.
The Patch is made of Polyganics’ proprietary bioresorbable and biologically safe polymers, and is designed to seal off the surgically treated tissue during the critical healing period. The polymer formation is specifically optimised for HPB surgery, as it can withstand the interference of aggressive bile and pancreatic fluids. The aim is to prevent post-operative leakage of fluids from the site of surgery into the abdominal cavity after HPB surgery, and control minimal to moderate bleeding.
“There is a clear need for a device that can effectively control the leakage of fluids in HPB surgery, that can be applied easily and can seal and withstand the enzymatic action and acid substances such as bile and pancreatic fluids,” said Professor Dr Jakob Izbicki, Chairman of the Department of General, Visceral and Thoracic Surgery, Surgeon-in-Chief, University Medical Center Hamburg-Eppendorf (UKE), Polyganics’ development partner for the Liver and Pancreas Sealant Patch. “If an effective closure of the surgically treated tissues can be achieved, post-operative morbidities such as infection, abdominal abscesses and sepsis, often leading to a prolonged hospital stay, will be significantly reduced, positively affecting patients’ post-operative quality of life.”