The balloon-expandable covered stent’s indication aligns with AIOD, which includes treating lesions at the aortic bifurcation.
Getinge said EU MDR certification highlights its dedication to providing safe, effective, high-quality products. With the European Union’s more stringent requirements, it also highlights the company’s commitment to regulatory standards. The company said all this combines with a focus on future expanded indications for use.
Advanta V12 treats patients with renal artery stenosis and/or aortoiliac occlusive disease, including lesions at the aortic bifurcation, when endovascular therapy is required. It offers a kissing stent configuration often recommended for challenging endovascular treatment of AIOD involving the aortic bifurcation.
“Receiving the new EU MDR certification is a proud moment for Getinge. It is a clear reflection of our strategic vision, accompanied by the hard work and persistence of our team. This investment in regulatory excellence not only supports our growth ambitions and future endeavors but also reinforces our commitment in making a positive impact on the lives of the patients we serve,” said Chad Carlton, VP of vascular systems at Getinge.
