Getinge iCast™ Covered Stent System Receives FDA Premarket Approval for Treatment of Iliac Arterial Occlusive Disease

Getinge iCast™ Covered Stent System has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.

As the most clinically evaluated balloon expandable polytetrafluoroethylene (ePTFE)-covered stent in the world, the iCast covered stent system, also sold outside of the US under the brand name Advanta V12 covered stent, has been trusted by clinicians for more than 20 years. Clinical use, documented in over 550 publications, includes long-term and real-world data.¹ 

“Getinge has a long history of providing physicians with treatment options in peripheral arterial disease. The PMA approval of the iCAST covered stent system expands the options for US physicians to treat patients with a clinically proven device,” says Chad Carlton, Vice President Vascular Surgery at Getinge.

In the iCARUS IDE trial, the iCast stent was reported to be safe and effective for treatment of iliac artery lesions. The 9-month primary patency rate was 96.4%, with a sustained benefit as evidenced by the 3-year “freedom from target lesion revascularization (fTLR)” rate of 86.6%.²

Recent systematic literature reviews have discussed the benefits of covered stents for complex aortoiliac lesions, with one reporting, “clear superiority of covered stents (for TASC C/D lesions) over non-covered stents³ and another concluding that, “covered balloon-expandable stents are preferred over bare metal stents for complex iliac lesions because of their (patency) benefits.”⁴ The iCast/Advanta V12, in particular, is the only covered stent with evidence from a randomized controlled study; that demonstrated better performance of the iCast stent relative to bare metal stents.⁵ It was also concluded, in the long-term (5 years), that iCAST has “an enduring patency advantage over the bare-metal stent”⁶. As the world population ages and rates of diabetes and obesity rise, it is estimated that more patients will be affected by iliac artery disease, driving an increase in peripheral artery interventional procedures to prevent more serious complications, such as critical limb ischemia or amputation. Iliac occlusive disease is a type of peripheral arterial disease (PAD), a serious condition that affects 8 million people in the US,6 in which atherosclerosis narrows and blocks peripheral arteries. AIOD develops when narrowing occurs in the iliac arteries, which supply blood to the legs and feet.

About Getinge

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions that aim to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 10,000 people worldwide and the products are sold in more than 135 countries.

¹Clinical bibiography on file at Getinge

²Laird, JR, Loja M, Zeller T, et al. iCast balloon-expandable covered stent for iliac artery lesions: 3-year results from the iCARUS multicenter study. J Vasc and Interv Rad. 2019;30:822-829.

³Mallory, A, Gioannapoulos, S, Lee, P, et al. Vasc and Endovasc Surg. 2021. 55(6:; 560-570.

⁴Mwipatayi, PB, Ouriel, K, Anwari, T, et al. A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease. J Vasc Surg. 2020:72,4:1473-1486.

⁵Mwipatayi, PB, Sharma, S, Daneshmand, A, et al. Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandablt Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease. ). J Vasc Surg. 2016:64(1):83-94.

⁶Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5–S67.