Polyganics said today it won FDA breakthrough device designation for its Liver and Pancreas Sealant Patch designed to prevent fluid leakage after hepato-pancreato-biliary procedures.
The Dutch company’s Liver and Pancreas Sealant Patch is made from a proprietary bioresorbable polymer designed to seal-off the surgically treated tissue during the critical healing period.
“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,” sealant patch development partner Dr. Jakob Izbicki of the University Medical Center Hamburg-Eppendorf said in a prepared statement.
Polyganics said that the proprietary materials for the sealant are specifically designed for HPB surgery to withstand bile and pancreatic fluids specific to that procedure, as well as to act as an adjunctive hemostatic device to control minimal to moderate bleeding.
“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,” Polyganics CEO Rudy Mareel said in a press release.
Last December, Polyganics said it was awarded a $1.4 million (EU €1.2 million) grant from the European Fund for Regional Development to support clinical validation of its dura sealant patch.