FDA Approves New Stent System from Abbott

Abbott Vascular, based in Abbott Park, Ill., has received approval from the U.S. Food and Drug Administration (FDA) for the Omnilink Elite Vascular Balloon-Expandable Stent System. The system is indicated for the treatment of iliac artery disease, a form of peripheral artery disease (PAD) that affects the lower extremities. Iliac artery disease can progress to where patients experience chronic pain and reduced ability to walk, potentially leading to permanent disability.

The FDA approval was supported by positive data from the Mobility clinical trial that examined both the Omnilink Elite and the Absolute Pro Vascular Self-Expanding Stent System, which was approved earlier this year. 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 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,” said Tony S. Das, M.D., FACC, director of peripheral vascular interventions in the Cardiology Section of the Presbyterian Heart Institute in Dallas, Texas, and co-principal investigator of the Mobility study. “At nine 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 PAD. With Mobility, we have new evidence that we can successfully treat patients with severe lesions with Omnilink Elite and achieve meaningful clinical results.”

Mobility was a prospective, non-randomized, two-arm, multi-center study conducted at 48 centers in the United States, evaluated the effectiveness of the Omnilink Elite and Absolute Pro in patients who had iliac artery disease with intermittent claudication or critical limb ischemia, including complex lesions. According to Abbott, 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, 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 or sides.

“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 of Medical Affairs and chief medical officer of Abbott Vascular.

Omnilink Elite and Absolute Pro are available in the United States, Europe, the Middle East and parts of Asia, with indications varying by geography. Balloon-expandable stents and self-expanding stents differ in how they are delivered to the lesion. Physicians typically choose which type of stent to use based on lesion location, complexity and the long-term prognosis of the patient.

Abbott Vascular is a subsidiary of Abbott Laboratories, and provides technology in the sectors of cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.