The U.S. Food and Drug Administration has approved Libertyville Township-based Abbott Laboratories' Omnilink Elite Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease, a form of peripheral artery disease that affects the lower extremities.
The FDA's approval is supported by positive clinical data from a study on the stent's use. The 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, Abbott said in a release.
"The 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 study. "
"Improving patient quality of life continues to be a key objective in the treatment of PAD," he added. "We have new evidence that we can successfully treat patients with severe lesions with Omnilink Elite and achieve meaningful clinical results."
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.
Peripheral artery disease affects approximately 8 million to 12 million people in the United States and occurs when the blood vessels outside of the heart become narrowed with plaque, fatty deposits that build up within the vessels. 1 While PAD is most commonly seen in the legs, blockages can also occur in the vessels that carry blood to the head, arms, kidneys and stomach.