Abbott has announced U.S FDA approval for its Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease.
The product has undergone FDA’s Premarket Approval (PMA) process and the agency’s approval order can be found here.
Iliac artery disease, a form of peripheral artery disease (PAD) that affects the lower extremities, affects 8 to 12 million people in the United States and can progress to a stage where patients experience chronic pain and reduced ability to walk, potentially leading to permanent disability.
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.
The device is based on the proven, market-leading MULTI-LINK stent design with a next-generation cobalt chromium alloy, specifically selected because it is stronger and more radiopaque than stainless steel. The company maintains that this renders it easy to see under X-ray while maintaining thin, flexible struts.
FDA’s 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.
MOBILITY clinical study
The MOBILITY study, a prospective, non-randomised, two-arm, multi-centre 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 304 patients who had iliac artery disease with intermittent claudication or critical limb ischemia, including complex lesions.
Abbott says the study is reflective of real-world clinical practice because it did not exclude patients with highly calcified lesions or severe peripheral vascular disease.
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.
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. 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 in Dallas, Texas, 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.”
“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.”
Source: Abbott Vascular, PR Newswire