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October 13, 2025
Getinge’s Advanta V12 Covered Stent Approved in Europe for Bridging Indications
October 13, 2025—Getinge announced that its Advanta V12 covered stent system has received approval in Europe for use as a bridging stent in fenestrated endovascular aneurysm repair (FEVAR), branched endovascular aneurysm repair (BEVAR), and iliac branch device (IBD) aneurysmal repair. The CE Mark approval was granted under the European Union Medical Device Regulation.
The company advised that the new approval expands the device’s existing indications for renal and aortoiliac occlusive disease.
“We’ve used Advanta V12 for years in advanced aortic procedures, and this CE Mark finally matches the evidence we’ve seen in practice,” commented Professor Tilo Kölbel, MD, in Getinge’s press release.
Prof. Kölbel, who is a vascular surgeon at University Hospital Hamburg-Eppendorf in Hamburg, Germany, continued, “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.”
In the United States, Advanta V12 is marketed as the iCast covered stent system, which received FDA premarket approval for bridging stent use in aneurysmal disease in July 2025, noted Getinge.
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