FDA Clears Omnilink Elite Vascular Balloon-Expandable Stent for Iliac Artery Lesions
Aug. 8, 2012 — The U.S. Food and Drug Administration (FDA) has approved Abbott’s Omnilink Elite Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease. This form of peripheral artery disease (PAD) that affects the lower extremities can progress to where patients experience chronic pain and reduced ability to walk, potentially leading to permanent disability.
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 Omnilink Elite stent 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 MOBILITY study demonstrated that treatment with Omnilink Elite resulted in an increase in quality of life in a difficult-to-treat patient population that is reflective of real clinical practice. At nine months, patients experienced significant improvements in walking distance and speed, and were able to climb more stairs than they could before treatment," said Tony S. Das, M.D., FACC, director, peripheral vascular interventions, cardiology section, Presbyterian Heart Institute, Dallas, and co-principal investigator of the MOBILITY study. "Improving patient quality of life continues to be a key objective in the treatment of PAD. With MOBILITY, we have new evidence that we can successfully treat patients with severe lesions with Omnilink Elite and achieve meaningful clinical results."
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.
"Omnilink Elite was shown to be safe and effective in the MOBILITY study, which evaluated patients with complex disease, including disease caused by severe calcification. Low rates of target lesion revascularization and significant improvements in walking ability reinforce the use of Omnilink Elite in real-world patients," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, medical affairs, and chief medical officer, Abbott Vascular. "Abbott is dedicated to improving the lives of patients with PAD by providing physicians with the most innovative therapies for treatment of this debilitating disease. The approval of Omnilink Elite and the recent FDA approval of Absolute Pro add to Abbott's already robust portfolio of advanced endovascular products for the treatment of PAD."
In the United States, the Omnilink Elite stent is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of ≥ 5 mm and ≤ 11 mm, and lesion lengths up to 50 mm.
For more information: www.abbottvascular.com/static/cms_workspace/pdf/ifu/peripheral_intervention/eIFU_Omnilink_Elite.pdf, www.abbott.com
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