Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Getinge received EU MDR certification for Advanta V12 stent

Getinge has obtained the European Union (EU) Medical Device Regulation (MDR) certificate for its Advanta V12-covered stent system, confirming compliance with EU standards. This extends the stent's indications for use, particularly for patients with aortoiliac occlusive disease (AIOD).

The Advanta V12 covered stent treats patients with renal artery stenosis and/or aortoiliac occlusive disease, including aortic bifurcation lesions, requiring endovascular therapy. With over two decades of service, it offers precision, versatility, and predictability, standing as the sole durable solution in its class, supported by extensive clinical evidence.

The fully encapsulated Advanta V12 stent aims to restore and enhance the patency of the iliac and renal arteries. Recently, Getinge obtained 510(k) clearance from the US Food and Drug Administration for its Vasoview Hemopro 3 endoscopic vessel harvesting solution for cardiovascular surgery. This solution enhances procedural efficiency and patient outcomes through features like enhanced smoke evacuation, regulated energy control, an ergonomic handle, and an integrated cable.