The Swedish medical technology firm said its iCast system is a clinically evaluated balloon expandable polytetrafluoroethylene (ePTFE)-covered stent and is marketed as Advanta V12 covered stent system outside the US
Swedish medical technology firm Getinge has secured the US Food and Drug Administration (FDA) premarket approval for its iCast covered stent system to treat patients with iliac arterial occlusive disease.
The company has been marketing the iCast stent system outside the US, under the brand name Advanta V12 covered stent.
Getinge designed the ultra-thin covering for the iCast system, using a unique PTFE film covering technology.
The 316L stainless steel struts are covered, safeguarding the flow lumen and the struts from contacting the luminal wall.
The technology expands uniformly to prevent tissue from prolapsing through the expanded stent.
iCast covered stent system is the most clinically evaluated balloon expandable polytetrafluoroethylene (ePTFE)-covered stent worldwide, said the company.
Getinge acute care therapies president Elin Frostehav said: “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.
“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 serious condition related to peripheral arterial disease (PAD), where atherosclerosis narrows down and blocks the peripheral arteries.
Getinge serves operating rooms, intensive-care units, sterilisation departments, life science companies and institutions.
In November 2021, Getinge acquired Verrix, a US-based medical device company that has developed a rapid biological indicator system for operating room sterilisation.