Getinge 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.