Getinge receives US FDA premarket approval for the iCast covered stent system

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iCast covered stent

Getinge‘s iCast covered stent system has received premarket approval from the US Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.

Iliac arterial occlusive disease is a type of peripheral arterial disease (PAD), which affects 8 million people in the USA. As the world population ages and rates of diabetes and obesity rise, it is estimated that more people will be affected with iliac artery disease.

“We are pleased that the iCast stent system is approved in the USA for use in iliac arteries to benefit an even greater number of patients,” says Elin Frostehav, president of acute care therapies at Getinge. “The global market for covered stents is growing at an annual rate of 5%. 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 USA under the brand name Advanta V12, 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.


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