amg International, a German part of Q3 Medical Devices Limited, an Irish company, won the CE Mark of approval for its ARCHIMEDES Biodegradable Biliary and Pancreatic Stent. The European approval gives the company the green light to introduce the device on the continent, with the clinical indication for placement within blocked biliary and pancreatic ducts. Of note, this is the world’s first bioabsorbable biliary and pancreatic stent.
Traditionally, such stents, designed to keep the ducts unobstructed, are typically made of plastic or metal. The ARCHIMEDES is made of a number of biodegradable materials that are combined to result in reliable break up times. As such, the device is available in three options, biodegrading in either 12 days, 20 days, or 11 weeks, depending on the one implanted. While it breaks apart, the design of the device allows the duct lumen to remain open, hopefully remaining unobstructed once the implant completely leaves the body.
“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,” said Eric K. Mangiardi, CEO of Q3. “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.”
Via: amg International…