FDA approves Abbott’s Omnilink Elite Vascular Balloon-Expandable Stent System for treatment of iliac arterial disease

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Omnilink Elite
Omnilink Elite

The US Food and Drug Administration (FDA) has approved the Omnilink Elite Vascular Balloon-Expandable Stent System (Abbott) for the treatment of iliac arterial disease. 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 even in difficult-to-treat patients with 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, director, Peripheral Vascular Interventions, Cardiology Section, Presbyterian Heart Institute, Dallas, Texas, USA, and co-principal investigator of the MOBILITY study. “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.”    

The MOBILITY study, a prospective, non-randomised, two-arm, multicentre study conducted at 48 centres in the United States, evaluated the effectiveness of two Abbott stents‰Û¥Absolute Pro Vascular Self-Expanding Stent System and Omnilink Elite Vascular Balloon-Expandable Stent System‰Û¥in patients who had iliac arterial disease with intermittent claudication or critical limb ischaemia, 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% 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<0.0001), which was developed from published literature on previous iliac arterial stenting studies. The major adverse event rate was defined as death due to any cause, myocardial infarction, clinically driven target lesion revascularisation 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 revascularisation and significant improvements in walking ability reinforce the use of Omnilink Elite in real-world patients,” said Charles A Simonton, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular.

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 arterial lesions with reference vessel diameters of greater than or equal to 5.0mm and less than or equal to 11.0mm, and lesion lengths up to 50mm.


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 4.3mm and 9.1mm and lesion lengths up to 90mm.

 

Omnilink Elite and Absolute Pro are available in the United States, Europe, the Middle East and parts of Asia. 

 

 

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