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October 30, 2023

Getinge’s iCast Covered Stent System Launched in United States

October 30, 2023—Getinge announced the commercial availability of the company’s iCast covered stent system in the United States for the treatment of iliac arterial occlusive disease. 

In March 2023, the company announced it had received FDA premarket approval for the iCast device for this indication.

The iCast balloon expandable polytetrafluoroethylene-covered stent is marketed outside the United States as Advanta V12, noted Getinge. As previously reported by the company, the iCARUS investigational device exemption trial demonstrated that the iCast stent was 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%.

Getinge will feature the iCast device at VIVA 2023, the Vascular InterVentional Advances conference held October 30-November 1 in Las Vegas, Nevada, and at the VEITHsymposium held November 14-18, 2023, in New York, New York.

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