Abbott has obtained the US Food and Drug Administration (FDA) approval for its Omnilink Elite Vascular Balloon-Expandable Stent system, designed as a treatment for atherosclerotic iliac artery lesions with reference vessel diameters of = 5.0 mm and = 11.0 mm, and lesion lengths up to 50 mm.
The Omnilink Elite stent, which features a Multi-Link stent design with a new cobalt chromium alloy, enables 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-center, non-randomized, prospective, MOBILITY study, designed to study 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 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," 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."