The US Food and Drug Administration (FDA) has cleared Abbott‘s Omnilink Elite vascular balloon-expandable stent system, which is designed as a treatment for atherosclerotic iliac artery lesions with reference vessel diameters of = 5.0mm and = 11.0mm, and lesion lengths up to 50mm.
The Omnilink Elite stent, which is based on the Multi-Link stent design with a cobalt chromium alloy, enables a physician to accurately place the device and navigate the stent in complex anatomy.
The FDA approval is based on the positive results of a multi-centre, non-randomised, prospective Mobility study, designed to assess the safety and efficacy of Omnilink Elite stent system.
The study met its primary endpoint with a nine-month major adverse event rate of 5.4% for patients treated with Omnilink Elite.
Presbyterian Heart Institute peripheral vascular interventions director and Mobility study co-principal investigator Tony S Das said the Mobility study showed that treatment with Omnilink Elite resulted in increased quality of life in a difficult-to-treat patient population.
"At nine months, patients experienced significant improvements in walking distance and speed, and were able to climb more stairs than they could before treatment," Das added.
"With Mobility, we have new evidence that we can successfully treat patients with severe lesions with Omnilink Elite and achieve meaningful clinical results."
Abbott Vascular chief medical officer and medical affairs divisional vice president Charles A Simonton said the company is dedicated to improve the lives of patients with peripheral artery disease (PAD) by providing physicians with new therapies.
"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."
Image: Abbott’s Omnilink Elite vascular balloon-expandable stent system, which treats atherosclerotic iliac artery lesions, has been approved by the FDA. Photo: U.S. Food and Drug Administration.