Getinge’s iCast Covered Stent System Receives FDA Approval for New Sizes

April 1, 2026—Getinge announced it has received FDA premarket approval for additional sizes of its iCast covered stent system. The approval includes a 10-mm diameter by 59-mm length, 32-mm lengths, and a 12-mm diameter.

The iCast device was first approved by the FDA in March 2023 for treatment of patients with iliac artery occlusive disease.

The newly approved sizes, which will be available this spring, enable the treatment of a broader range of vessel and lesion diameters and lengths with increased procedural flexibility, stated the company.

According to the Sweden-based company, the iCast covered stent system, including the newly approved sizes, will continue to be distributed in the United States through Getinge’s collaboration with Cook Medical that was initiated in March 2024.

“We are excited to bring this important portfolio expansion to the United States market,” commented Chad Carlton, Vice President Endovascular Solutions at Getinge, in the company’s press release. “Physicians outside the United States have long benefitted from a broader size offering when treating patients with our Advanta V12 covered stent system, which features an identical device design to the iCast covered stent. We are pleased to now offer these additional sizes to United States physicians within the iCast covered stent product family.”