Abbott's Omnilink Elite® Vascular Balloon-Expandable Stent System Receives FDA Approval for Treatment of Iliac Artery Disease
Approval Based on Positive Clinical Evidence From the MOBILITY Study, Involving Real-World Patients with Complex Disease
ABBOTT PARK, Ill., Aug. 7, 2012 – Abbott today announced that the U.S. Food and Drug Administration (FDA) approved the Omnilink Elite® Vascular Balloon-Expandable Stent System 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 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 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, MD, FACC, director, Peripheral Vascular Interventions, Cardiology Section, Presbyterian Heart Institute in Dallas, Texas, and co-principal investigator of the MOBILITY study.
The MOBILITY study, a prospective, non-randomized, two-arm, multi-center 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, MD, FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular.
Omnilink Elite is the newest addition to Abbott's U.S. portfolio of endovascular products for the treatment of PAD, including balloon dilatation catheters to treat blockages in the lower extremities and vascular stents to open blocked kidney and carotid arteries.
About the Omnilink Elite Vascular Balloon-Expandable Stent System
In the United States, the Omnilink Elite Vascular Balloon-Expandable Stent System is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of ≥ 5.0 mm and ≤ 11.0 mm, and lesion lengths up to 50 mm. Specific information about the Omnilink Elite Vascular Balloon-Expandable Stent System, including important safety information, is available online at: http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/peripheral_in...
About the Absolute Pro Vascular Self-Expanding Stent System
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. Specific information about the Absolute Pro Vascular Stent System, including important safety information, is available online at: http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/peripheral_in...
Omnilink Elite and Absolute Pro are available in the United States, Europe, the Middle East and parts of Asia. Indications vary by geography.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com