FDA Approves Abbott Vascular's Omnilink Elite to Treat Iliac Artery Disease

August 7, 2012—Abbott Vascular (Santa Clara, CA) announced that the US Food and Drug Administration (FDA) approved the Omnilink Elite vascular balloon-expandable stent system for the treatment of iliac artery disease. In the United States, the Omnilink Elite 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. The Omnilink Elite is now available in the United States, Europe, the Middle East, and parts of Asia, with indications varying by geography.

The Omnilink Elite stent is based on the company's Multi-Link stent, with a next-generation cobalt chromium alloy designed to provide more strength and radiopacity than stainless steel and more visible under x-ray.

The company stated that the FDA approval is supported by clinical data from the MOBILITY (Omnilink Elite or Absolute Pro Stent Used in the Iliac Artery) study. The MOBILITY data demonstrated that the 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 study is a prospective, nonrandomized, two-arm, multicenter study conducted at 48 centers in the United States. MOBILITY evaluated the effectiveness of two Abbott stents—the 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.

Abbott describes the study as reflective of real-world clinical practice because it did not exclude patients with highly calcified lesions or severe peripheral vascular disease.

As summarized in the company's release, 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 9-month major adverse event rate of 6.1% for patients treated with Absolute Pro and 5.4% for patients treated with Omnilink Elite. These rates were significantly below the primary endpoint goal of 19.5% (P < .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, 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 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,” commented Tony S. Das, MD, Co-Principal Investigator of the MOBILITY study. “At 9 months, patients experienced significant improvements in walking distance and speed, and were able to climb more stairs than they could before treatment. Improving patient quality-of-life continues to be a key objective in the treatment of peripheral arterial disease. With MOBILITY, we have new evidence that we can successfully treat patients with severe lesions with Omnilink Elite and achieve meaningful clinical results.”

In the United States, the Absolute Pro vascular self-expanding stent system is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4.3 mm and 9.1 mm and lesion lengths up to 90 mm. Absolute Pro is available in the United States, Europe, the Middle East, and parts of Asia; indications vary by geography.