Getinge’s Advanta V12 Covered Stent System Receives EU MDR Certification

April 11, 2024—Sweden-based Getinge announced the European Union Medical Device Regulation (EU MDR) certification of its Advanta V12 covered stent system. The CE Mark-approved device has been available in Europe for approximately 20 years.

According to the company, the Advanta V12 covered stent system is indicated for treating patients diagnosed with renal artery stenosis and/or aortoiliac occlusive disease (AIOD), including lesions at the aortic bifurcation, when endovascular therapy is required.

The device is designed to address the challenges of endovascular treatment of AIOD involving the aortic bifurcation. When AIOD involves the aortic bifurcation or proximal common iliac arteries, a kissing stent configuration is recommended, noted the company.

The company stated that EU MDR certification for Advanta V12 highlights Getinge’s dedication to providing safe, effective, high-quality products; its commitment to regulatory standards; and its focus on future expanded indications for use.

The Advanta V12 is marketed in the United States as the iCast balloon-expandable polytetrafluoroethylene-covered stent. In March 2023, Getinge announced FDA premarket approval for the iCast device for the treatment of iliac arterial occlusive disease. The device’s commercial availability in the United States was announced in October 2023. In March 2024, Getinge and Cook Medical announced an exclusive sales and distribution agreement for Getinge’s iCast covered stent system in the United States.