Getinge recieves FDA premarket approval for the iCast™ covered stent system in the US
GOTHENBURG, Sweden, March 24, 2023 /PRNewswire/ -- Getinge's iCast™ covered stent system has received premarket approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.
- GOTHENBURG, Sweden, March 24, 2023 /PRNewswire/ -- Getinge's iCast™ covered stent system has received premarket approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.
- "We are pleased that the iCast™ stent system is approved in the United States for use in iliac arteries to benefit an even greater number of patients", says Elin Frostehav, President Acute Care Therapies at Getinge.
- Getinge will continue to ramp up capacity throughout the year in order to meet the demand."
- The iCast covered stent system, which is sold outside the US under the brand name Advanta V12 covered stent, has been used by clinicians for 20 years and is the most clinically evaluated balloon expandable polytetrafluoroethylene (ePTFE)-covered stent in the world, with clinical data published in more than 550 articles.