The covered stent system is indicated for use with patients suffering from aortoiliac occlusive disease (AIOD), including lesions at the aortic bifurcation, meaning the regulatory approval shows that the system aligns with the EU’s medical device regulations
Getinge’s Advanta V12 covered stent system. (Credit: Getinge)
Swedish medical technology company Getinge has secured the European Union Medical Device Regulation (EU MDR) certification for its Advanta V12 covered stent system.
The covered stent system is intended for use with patients suffering from aortoiliac occlusive disease (AIOD), including lesions at the aortic bifurcation.
The regulatory approval shows that the system aligns with the EU’s medical device regulations.
Getinge said that its Advanta V12 covered stent system features versatility, precision, and predictability.
The system, backed by decades of clinical and real-world evidence, has been addressing the needs of surgeons and patients for more than 20 years, said the medical device maker.
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.
“This investment in regulatory excellence not only supports our growth ambitions and future endeavours but also reinforces our commitment in making a positive impact on the lives of the patients we serve.”
Getinge said that endovascular treatment of aortoiliac occlusive disease (AIOD) involving the aortic bifurcation is challenging.
A kissing stent configuration is recommended when aortoiliac occlusive disease involves the aortic bifurcation or proximal common iliac arteries.
The Advanta V12 covered stent system is indicated for treating patients with renal artery stenosis or aortoiliac occlusive disease, including lesions at the aortic bifurcation.
It is the first expandable balloon, a fully encapsulated stent that has served more than 850,000 patients and has met the needs of surgeons and patients for 20 years, said Getinge.