Omnilink Elite Stent Offers Balloon-Expandable Option for Iliac Lesions
The Abbott Omnilink Elite Vascular Balloon-Expandable Stent System is indicated for the treatment of iliac artery lesions with reference vessel diameters of ≥ 5 mm and ≤ 11 mm, and lesion lengths up to 50 mm. It is based on the proven, market-leading Multi-Link stent design with a next-generation cobalt chromium alloy. Cobalt chromium is stronger and more radiopaque than stainless steel, making the stent easy to see under X-ray while maintaining thin, flexible struts. These features are designed to enable the physician to navigate the stent in complex anatomy and facilitate accurate placement of the device – important for long-term patient outcomes.
The FDA approval is supported by positive clinical data from the MOBILITY (Omnilink Elite or Absolute Pro Stent Used in the Iliac Artery) study. The MOBILITY study demonstrated that Omnilink Elite is safe and effective, including when used for patients who are difficult-to-treat due to complex disease resulting from severely calcified lesions.
The MOBILITY study, a prospective, nonrandomized, two-arm, multicenter study conducted at 48 centers in the United States, evaluated the effectiveness of two Abbott stents – Absolute Pro Vascular Self-Expanding Stent System and Omnilink Elite Vascular Balloon-Expandable Stent System – in patients who had iliac artery disease with intermittent claudication or critical limb ischemia, including complex lesions. The study is reflective of real-world clinical practice because it did not exclude patients with highly calcified lesions or severe peripheral vascular disease. Of the 304 patients enrolled in the study, 151 were treated with Absolute Pro and 153 were treated with Omnilink Elite. The study met its primary endpoint: a nine-month major adverse event rate of 6.1 percent for patients treated with Absolute Pro and 5.4 percent for patients treated with Omnilink Elite. These rates were significantly below the primary endpoint goal of 19.5 percent (p<0.0001), which was developed from published literature on previous iliac artery stenting studies. The major adverse event rate was defined as death due to any cause, heart attack (myocardial infarction), clinically driven target lesion revascularization and limb loss (major amputation only) on the treated side(s). Walking ability significantly improved for patients in both arms of the study.
The U.S. Food and Drug Administration (FDA) approved the Abbott’s Omnilink Elite Vascular Balloon-Expandable Stent System in August 2012.
For more information: www.abbottvascular.com/static/cms_workspace/pdf/ifu/peripheral_intervention/eIFU_Omnilink_Elite.pdf, www.abbott.com