Q3 Medical Devices’ AMG International said today it won CE Mark approval in the European Union for its Archimedes biodegradable biliary and pancreatic stent.
The Winsen, Germany-based company touts the Archimedes as the only fully biodegradable biliary and pancreatic stent cleared for use in obstructed biliary or pancreatic ducts globally.
“The Archimedes biodegradable stent represents a major breakthrough in the treatment of obstructive biliary and pancreatic disorders, and also in the field of biodegradable and bioresorbable materials and their application in medical devices moving forward. This technology has numerous benefits for patients, doctors, and healthcare providers as it has the potential to reduce complication rates typically associated with plastic stents and removal procedures,” Q3 CEO Eric Mangiardi said in a prepared statement.
The Archimedes stent is designed to degrade completely via hydrolysis in approximately 12, 20 or 77 days depending on its composition.
“This CE Mark approval is a major advancement in the treatment of obstructive biliary and pancreatic disorders and provides physicians such as myself, a truly innovative and advanced treatment option for my patients,” Dr. Sundeep Lakhtakia of Hyderabad, India’s Asian Institute of Gastroenterology said in a prepared release.
Results from a recent safety and efficacy clinical study the company ran in India and Malaysia indicated zero stent related complications across 53 patients, AMG said.
“This is great news, as a fully biodegradable stent has the potential to reduce complication rates and procedural costs typically associated with biliary and pancreatic stenting,” Dr. Paul Yeaton of Roanoke, Va.’s Carilion Clinic said in a press release.