Abbott stent system gains iliac artery disease treatment approval

Abbott ($ABT) won another stent system approval it can crow about. The FDA signed off on its Omnilink Elite vascular balloon-expandable stent system to treat iliac artery disease.

The indication addresses a form of peripheral artery disease that can specifically hit the lower extremities, causing pain and impaired walking, the company notes. Of course, the market is bursting at the seams with all kinds of stents at this point, and Abbott promotes the daylights out of its new product to show how it stands out. It's made of cobalt chromium, rather than stainless steel, the company points out, making the stent easier to see under an X-ray. The new stent also has "thin, flexible struts" designed to help physicians more easily navigate the device through difficult parts of the body and make sure it is left in the right spot.

Abbott's MOBILITY study supported the approval--a prospective, non-randomized, two-arm multi-center study conducted at 48 U.S. sites with 304 patients. Abbott compared its Omnilink Elite to its Absolute Pro vascular self-expanding stent system, and both were tested in patients who had iliac artery disease with either intermittent claudication or critical limb ischemia. Abbott said it met its primary endpoint, with a 5.4% adverse event rate over 9 months for patients treated with Omnilink Elite, and a 6.1% adverse event rate for patients treated with Absolute Pro. Both were below the company's 19.5% primary endpoint goal. Abbott treated 151 patients with Absolute Pro, and 153 with Omnilink Elite.

Abbott plans to separate into two publicly traded companies. The medical products division will keep Abbott's name. AbbVie will be the name of the drug division once it becomes independent.

- read the release

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