Getinge’s Advanta V12 receives CE Mark for major bridging indications
Advanta V12 Covered Stent System has received CE Mark approval under the European Union Medical Device Regulation (EU MDR) for use as a bridging stent in fenestrated endovascular aneurysm repair (FEVAR), branched endovascular aneurysm repair (BEVAR), and iliac branch device (IBD) aneurysmal repair.
“This CE Mark reflects our long-standing commitment to physicians and patients facing advanced stage vascular disease,” says Chad Carlton, Vice President Endovascular Solutions at Getinge. “Advanta V12 has earned its place in complex repair strategies through dependable, proven performance. Today, that performance is officially recognized for FEVAR, BEVAR, and IBD bridging — all in one device.”
Versatility
Advanta V12 has long been a cornerstone in advanced aortic procedures, with nearly one million devices implanted globally and more than 100 peer-reviewed publications supporting its performance, describes Getinge.
The CE Mark approval adds to Advanta V12’s existing indications for renal and AIOD, reinforcing its versatility across a wide spectrum of aortic and peripheral anatomies. With this expanded approval, physicians can now rely on a single, proven platform to treat both complex aneurysmal and occlusive disease with confidence and precision.
Advanta V12 is marketed as the iCast covered stent system in the United States, where it received FDA Premarket Approval (PMA) for bridging stent use in aneurysmal disease in July 2025.
Published: October 14, 2025
