Polyganics manufactures and commercializes bioresorbable medical devices. Today they announced that the US Food and Drug Administration has granted Polyganics’ request for Breakthrough Device designation to its Liver and Pancreas Sealant Patch. The Liver and Pancreas Sealant patch is considered a unique breakthrough in the prevention of fluid leakage after hepato-pancreato-biliary (HPB) procedures, for which currently no approved or cleared alternatives exist.
The company reports the Liver and Pancreas Sealant Patch is made of Polyganics’ proprietary bioresorbable and biologically safe polymers, designed to seal-off the surgically treated tissue during the critical healing period. The polymer formulation of the Liver and Pancreas Sealant has been optimized specifically for HPB surgery, withstanding the interference of aggressive bile and pancreatic fluids. It aims to prevent post-operative leakage of fluids from the site of surgery into the abdominal cavity after HPB surgery, and as an adjunctive hemostatic device to control minimal to moderate bleeding.
A ‘Breakthough Device’ is a device that may prevent or treat a life-threatening or irreversibly debilitating disease or condition. Under the Breakthrough Devices program, the FDA will provide its support to advance the Liver and Pancreas Sealant Patch from development to marketing decision. As part of this, the FDA is committed to be closely involved in the design of efficient and flexible clinical trials, as well as the collection of pre- and post-market data. It is anticipated that this support, combined with priority review, will enable a reduced regulatory timeline.
Prof. Dr. Med. 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, commented: “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. 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.”
Rudy Mareel, CEO of Polyganics, commented: “We are excited about the FDA’s decision to grant Breakthrough Device designation to our Liver and Pancreas Sealant Patch. It is a great recognition of the potential clinical benefit this device may offer to patients. We look forward to working with the FDA to progress the device more swiftly to market and thereby drive better outcomes for surgical patients.”