The first product in our General Surgery portfolio is ACTISEAL®. ACTISEAL® is indicated for use to reduce 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
Fluid Leakage Reduction in Hepato-Pancreas-Biliary Surgery
Hepato-pancreato-biliary (HPB) surgery is a challenging branch of general surgery. Post-operative recovery is commonly impacted by complications from bleeding and fluid leakage, which can result in infection, abdominal abscesses and sepsis, leading to prolonged hospital stays and diminished quality of life.
There is currently no approved, clinically effective treatment options to reduce fluid leakage after HPB procedures. There is a vital need for easy-to-use sealants capable of reducing fluid leakage into the abdominal cavity and controlling post-operative bleeding and leakage.
We are developing ACTISEAL® – a Liver and Pancreas Sealing Patch using our proprietary bioresorbable and biologically safe polymers. The device is designed to seal-off surgically treated tissues during the critical healing period, then degrade via the body’s natural systems.
The polymer formulation of ACTISEAL® is optimized specifically for HPB surgery, to withstand interference from enzymatic action and acidic substances such as bile and pancreatic fluids. The patch-like device is designed to reduce post-operative leakage of fluids from the site of surgery into the abdominal cavity, and as an adjunctive hemostatic device to control minimal to moderate bleeding.
The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to our Liver and Pancreas Sealing Patch, identifying it as a unique breakthrough in the reduction of fluid leakage after HPB procedures, for which no approved or cleared alternatives currently exist. Read more about the designation here.
We are working closely with the surgical department of the University Medical Center Hamburg-Eppendorf (UKE) to develop ACTISEAL®
Enrollment for the SHIELDS trial is currently ongoing. This trial is a prospective, multicenter study, evaluating the safety and performance of ACTISEAL® in reducing fluid leakage following elective hepato-pancreato-biliary (HPB) surgery. The trial will involve 80 adult patients, enrolled and treated across seven renowned European clinical centers.
ACTISEAL® is classified as a class III medical device in Europe and the US, pending CE and FDA approval. ACTISEAL® is not commercially available.