Getinge has received the European Union (EU) Medical Device Regulation (MDR) certificate for its Advanta V12 covered stent system.
This certification affirms the system’s compliance with EU standards for medical devices.
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It also extends the stent’s indications for use, specifically for patients with aortoiliac occlusive disease (AIOD).
The Advanta V12 covered stent system is designed for the treatment of patients diagnosed with renal artery stenosis and/or aortoiliac occlusive disease, including lesions at the aortic bifurcation, when endovascular therapy is needed.
It has precision, versatility and predictability and has been serving the medical community for over two decades. It is said to be the only durable solution in its category, supported by extensive clinical and real-world evidence.
Getinge Vascular Systems vice-president Chad Carlton said: “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.
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By GlobalData“This investment in regulatory excellence not only supports our growth ambitions and future endeavours but also reinforces our commitment to making a positive impact on the lives of the patients we serve.”
The fully encapsulated Advanta V12 stent has been designed to restore and improve the patency of the iliac and renal arteries.
Last month, Getinge secured the US Food and Drug Administration’s 510(k) clearance for its Vasoview Hemopro 3 endoscopic vessel harvesting solution for cardiovascular surgery.
The solution is designed to improve procedural efficiency and patient outcomes, with features such as enhanced smoke evacuation, regulated energy control, an ergonomic game controller-style handle, and an integrated cable.
