Getinge’s 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 approval offers physicians a trusted, on-label solution backed by over two decades of clinical use, Getinge said in a press release announcing the development. The company describes Advanta V12 as a “cornerstone” in advanced aortic procedures, with nearly one million devices implanted globally and more than 100 peer-reviewed publications supporting its performance.
The device features a stainless-steel design with full ePTFE encapsulation to ensure radial support and dependable sealing, with an open-cell architecture to provide flexibility to adapt to complex anatomies.
“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 recognised for FEVAR, BEVAR, and IBD bridging—all in one device.”
The CE Mark approval adds to Advanta V12’s existing indications for renal and aortoiliac occlusive disease (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.
“We’ve used Advanta V12 for years in advanced aortic procedures, and this CE mark finally matches the evidence we’ve seen in practice,” says Tilo Kölbel, vascular surgeon at University Hospital Hamburg-Eppendorf (Hamburg, Germany). “To now have a single, proven device that’s approved for bridging in FEVAR, BEVAR, and IBD aneurysmal repair is a huge step forward, not just in regulatory clarity, but in simplifying and optimising patient care.”
Advanta V12 is marketed as the iCast covered stent system in the USA, where it received US Food and Drug Administration (FDA) premarket approval (PMA) for bridging stent use in aneurysmal disease in July 2025, further strengthening its global regulatory alignment.
