Getinge announced that its Advanta V12 covered stent system has earned CE mark approval under the 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.

Advanta V12 has been implanted almost a million times globally and boasts over 100 peer-reviewed publications supporting its performance, according to the company. It features a stainless-steel design with full ePTFE encapsulation to ensure radial support and dependable sealing. An open cell architecture provides the necessary flexibility to adapt to complex anatomies.

The system’s low-profile, flexible delivery and consistent deployment also enable precise placement and optimal seal integrity, even in challenging cases, Getinge said.

“This CE mark reflects our long-standing commitment to physicians and patients facing advanced stage vascular disease,” said Chad Carlton, VP 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.”

Approval in the EU adds to Advanta V12’s indications for renal and AIOD. With the expanded approval, physicians now have a single platform to treat both complex aneurysmal and occlusive disease.

In the U.S., Advanta V12 is marketed as the iCast covered stent system. It received U.S. Food and Drug Administration (FDA) premarket approval for bridging stent use in aneurysmal disease in July.

“We’ve used Advanta V12 for years in advanced aortic procedures, and this CE Mark finally matches the evidence we’ve seen in practice,” said Prof. Tilo Kölbel, vascular surgeon at University Hospital Hamburg-Eppendorf, 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 optimizing patient care.”