FDA approves balloon expandable stent system

Published date : 11 August 2012
Article date : 09 August 2012

Abbott has won FDA approval for the Omnilink Elite balloon expandable stent system which is the latest in the company's range of peripheral vascular intervention devices. The device is used in the treatment of atherosclerotic iliac artery lesions, a condition affecting the lower extremities which can lead to chronic pain, difficulty with walking or permanent disability. 

The Omnilink system is based on Abbott's Multi-Link coronary stent's design but it is manufactured from a cobalt-chromium alloy which, according to the company, is stronger than stainless steel and more easily visible in imaging.
FDA approval was supported by data from Abbott's Mobility study which compared the Omnilink Elite stent system alongside the Absolute Pro stent system. Both devices performed well under the major adverse event goal of 19.5% even among patients with difficult-to treat lesions. The Omnilink Elite resulted in a 5.4% MAE rate and the Absolute Pro in a 6.1% rate. MAEs were defined as death due to any causes, myocardial infarction, clinically-driven target lesion revascularisation and limb loss via major amputation on the treated side.

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