Medical devices giant Polyganics gains FDA breakthrough designation

Polyganics, a renowned company that develops and manufactures bioresorbable medical devices has recently reported that it has won the US Food and Drug Administration (FDA) Breakthrough Device designation for its Pancreas and Liver Sealant Patch. Apparently, these patches are deemed to be a unique breakthrough as they are designed to block the fluid leakage after the hepato-pancreato-biliary (HPB) surgery.

According to reports, the sealant patch is made of the company’s proprietary biologically safe and bioresorbable polymers developed to seal off the tissues that are surgically treated during the healing period. Sources cite that this polymer formulation has been particularly optimized to withstand the aggressive bile & pancreatic fluids of the HPB surgery.

Experts deem that the company’s polymer platform technologies are also likely to have a marginal impact on the growth prospects of polymers and advanced materials industry. The company’s unique development of bioresorbable polymers that are used to manufacture medical devices, according to experts is an apt example of how the healthcare and polymer sectors have merged to develop a perfect blend of advanced materials.

Dr. Jakob Izbicki of the University Medical Center Hamburg-Eppendorf and the development partner of the Liver and Pancreas sealant patch was quoted stating that the healthcare industry is in clear need of such devices that could effectively control leakage of bile and fluids in HPB procedures. Due to advancements in the polymers and advanced materials industry, the patch developed could significantly withstand acid substance and the enzymatic action in tissue seal. He further added that sealant patch would significantly reduce the post-operative morbidities such as abdominal abscesses, infection, and sepsis that often lead to prolonged hospital stay.

According to the Mass Device, the European Fund for Regional Development has granted USD 1.4 million to Polyganics to support its clinical validation of dura sealant patch.