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Getinge wins FDA PMA for iCast covered stent

March 27, 2023 By Danielle Kirsh

Getinge logoGetinge recently announced its iCast covered stent received FDA premarket approval to treat patients with iliac arterial occlusive disease.

The iCast covered stent is a clinically-evaluated balloon expandable polytetrafluoroethylene-covered stent. It is delivered using a catheter to hold open and support the walls of structures within the body. Renal approval of the device includes 5mm, 6mm and 7mm diameter sizes.

“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,” Elin Frostehav, president of acute therapies at Getinge, said in a news release. “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.”

Iliac arterial occlusive disease is a type of peripheral arterial diseases in which atherosclerosis narrows and blocks peripheral arteries. The disease affects 8 million people in the U.S., according to Getinge.

Filed Under: Balloons, Catheters, Stents Tagged With: Getinge

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

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