The Magle Group today announces that it will commence its post market clinical study in collaboration with the University of Heidelberg, Medical Faculty a world leading center in pancreatic surgery.
SmartPAN® is a patented first-in-class medical device developed jointly with the University of Heidelberg and Magle Chemoswed AB. SmartPAN® is based on the patented bio-compatible and bio-degradable microsphere technology (DSM) owned by Magle Chemoswed.
Postoperative pancreatic fistula (POPF) is a common and potentially life-threatening complication after pancreatic surgery. POPF can develop due to leaking pancreatic fluid. SmartPAN® acts as an intraoperative indicator of leakage by providing a near-immediate and accurate colour indication when in contact with the pancreatic fluid. SmartPAN® provides a less complicated approach to identifying and localising pancreatic leaks that benefits patient outcomes.
"The start-up of this PMCF study is a positive step forwards for SmartPAN® and gets us closer to benefitting patients through the use of SmartPAN®," said Bodil Gesslein, Project and Clinical Manager.
"We are very happy to perform a stage I first-in-human study according to IDEAL recommendations to evaluate the innovative SmartPAN® leakage indicator with the support of Magle at our study center in Heidelberg” said Thomas Pausch, assistant principle investigator from the Heidelberg trial team.
"We are all very excited to start this PMCF study with the results expected at this year's tail end. Our sponsoring of this study is further evidence of our commitment to clinical and scientific robustness of our DSM products," said Justin Pierce, CEO of Magle Group.