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March 24, 2023
Getinge’s iCast Covered Stent System Approved by FDA to Treat Iliac Arterial Occlusive Disease
March 24, 2023—Getinge announced that the company’s iCast expandable polytetrafluoroethylene- (ePTFE-) covered stent system has received FDA premarket approval for the treatment of patients with iliac artery occlusive disease.
According to the company, the iCast balloon ePTFE-covered stent is marketed outside the United States as Advanta V12.
In the iCARUS investigational device exemption trial, the iCast stent was reported to be safe and effective for the treatment of iliac artery lesions. The 9-month primary patency rate was 96.4%, with a sustained benefit as evidenced by a 3-year freedom from target lesion revascularization of 86.6%.
The iCast/Advanta V12 is supported by evidence from a randomized controlled study that demonstrated better performance of the iCast stent relative to bare metal stents. Additionally, long-term, 5-year findings confirmed the advantage of iCast over bare metal stents.
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