Be first to read the latest tech news, Industry Leader's Insights, and CIO interviews of medium and large enterprises exclusively from Medical Tech Outlook
THANK YOU FOR SUBSCRIBING
By
MedTech Outlook | Monday, November 23, 2020
Polyganics responds directly to the demands of surgeons and the needs of patients with ACTISEAL.
FREMONT, CA: Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, announces treatment of the first patients in its first-in-human study for ACTISEAL, its Liver and Pancreas Sealant Patch. The SHIELDS trial is a prospective, multicenter study, evaluating the safety and performance of ACTISEAL in mitigating fluid leakage following elective hepato-pancreato-biliary (HPB) surgery. The trial will have 80 adult patients, enrolled and treated across seven popular European clinical centers.
Stay ahead of the industry with exclusive feature stories on the top companies, expert insights and the latest news delivered straight to your inbox. Subscribe today.
Despite postoperative fluid leakage is a common complication of HPB procedures, with potentially life-threatening consequences, there is presently no clinically effective treatment available. As a result of this high unmet requirement combined with Polyganics convincing research data, the US Food and Drug Administration (FDA) awarded the Companys Liver and Pancreas Sealant Patch a Breakthrough Device Designation in 2018.
ACTISEAL works both as a sealant, withstanding the effect of aggressive bile and pancreatic fluids, and a hemostat, controlling mild-to-moderate bleeding. The easy-to-use, complete synthetic device is optimized to adhere to and seal the treated tissue throughout the healing period following HPB surgery. After this, it degrades securely within the body.
Fluid leakage is a significant complication of hepato-pancreato-biliary (HPB) procedures and is a significant healthcare burden. With life-threatening consequences like infection, abdominal abscesses and sepsis, postoperative leakage of aggressive enzymatic fluids into the abdominal cavity. There is a clear and urgent need for a device capable of effectively controlling fluid leakage following HPB surgery. Such postoperative leakage represents a high burden to both patients well-being and the healthcare system. The initiation of the first-in-human trial is a significant step towards mitigating leakage associated complications, which adversely affect surgical success and patient outcomes.
As the first offering to enter the clinic from General Surgery portfolio, ACTISEAL is spearheading Polyganics expansion into this challenging field. The patch is key to the strategy to increase the strength and breadth of the offering by diversifying pipeline of bioresorbable tissue support, repair and regeneration devices.
More in News
I agree We use cookies on this website to enhance your user experience. By clicking any link on this page you are giving your consent for us to set cookies. More info
