Getinge receives EU MDR approval of Advanta V12 covered stent system with use for patients with renal artery stenosis and/or aortoiliac occlusive disease
Getinge announces the EU MDR certification of its Advanta V12 covered stent system, highlighting its use for patients with aortoiliac occlusive disease, including lesions at the aortic bifurcation. This approval affirms the system's compliance with European Union medical device regulations and aligns its application, reflecting Getinge's commitment to quality and patient safety.
Getinge, a pioneer in balloon-expandable covered stents, announces the recent achievement of an EU MDR certificate for Advanta V12, that now aligns the indication to Aortoiliac Occlusive Disease (AIOD). The certification marks a significant milestone in the medtech company’s journey towards excellence and compliance in the global market.
Furthermore, the achievement highlights Getinge’s dedication to providing safe, effective, high-quality products and ongoing commitment to regulatory standards, combined with focus on future expanded indications for use.
Endovascular treatment of aortoiliac occlusive disease (AIOD) involving the aortic bifurcation is challenging. When aortoiliac occlusive disease involves the aortic bifurcation or proximal common iliac arteries, a kissing stent configuration is recommended. The Advanta V12 covered stent system is indicated for treating patients diagnosed with renal artery stenosis and/or aortoiliac occlusive disease, including lesions at the aortic bifurcation, when endovascular therapy is required.
“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,” says Chad Carlton, Vice President of Vascular Systems at Getinge.
The Advanta V12 covered stent system is known for its versatility, precision and predictability; has been meeting the needs of surgeons and patients for more than 20 years and is the only durable solution backed by decades of clinical and real-world evidence.