March 7, 2012
/PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) approved the Absolute Pro® Vascular Self-Expanding Stent System for the treatment of iliac artery disease, a form of peripheral artery disease (PAD) that affects the lower extremities. Over time, iliac artery disease can progress to where patients have reduced walking ability, experience chronic pain and suffer permanent disability. This approval is supported by the MOBILITY (Omnilink Elite® or Absolute Pro Stent Used in the Iliac Artery) study, which demonstrated that Absolute Pro is safe and effective, even in patients with complex disease.
"Iliac artery disease greatly impacts patients' overall quality of life," said
Tony S. Das
, M.D., FACC, director, Peripheral Vascular Interventions, Cardiology Section, Presbyterian Heart Institute in
, and co-principal investigator of the MOBILITY trial. "The goal of treatment is to open narrowed iliac arteries to restore blood flow to the legs, thereby alleviating pain and improving the patient's ability to walk farther and enjoy a more active lifestyle. With Absolute Pro, U.S. physicians now have an additional option that is proven safe and effective to treat many patients with this debilitating disease."
Absolute Pro is a self-expanding nitinol stent system made of a flexible material designed to allow the stent to conform to challenging lesions. It incorporates advanced technologies for optimal stent visibility, with a delivery system that is designed to minimize friction during stent deployment and ensure precise stent placement at the lesion site.
The FDA approval was supported by the results of the Absolute Pro arm of the MOBILITY trial, a prospective, non-randomized, two-arm, multi-center study that evaluated two
stents, Absolute Pro and Omnilink Elite, in patients with iliac artery disease. In the Absolute Pro arm, 151 patients with iliac artery disease were enrolled at 33 centers in
the United States
. The study met its primary endpoint, with a nine-month major adverse event rate of 6.1 percent (p<0.0001). This result was found to be significantly lower than the performance goal of 19.5 percent, which was developed from published literature on previous iliac artery stenting studies. The major adverse event rate was defined as death due to any cause, heart attack (myocardial infarction), clinically driven target lesion revascularization and limb loss (major amputation only) on the treated side(s). The results of the Omnilink Elite arm of the study will be available later this year.
"Compared to other clinical trials for iliac artery disease, the MOBILITY study enrolled a high percentage of patients with complex disease – those with highly calcified lesions, total occlusions and multi-level disease – which is a more accurate reflection of what physicians may see in their everyday practice," said
Charles A. Simonton
, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "In this difficult-to-treat population, Absolute Pro demonstrated strong clinical results, including significant improvement in overall quality of life, which is a tremendous outcome for patients with PAD.
's Absolute Pro provides physicians with an important addition for the treatment of iliac artery disease, and is an example of the company's commitment to developing advanced endovascular therapies for patients."
Absolute Pro is the newest addition to
's growing U.S. portfolio of endovascular products for the treatment of PAD. These products include balloon dilatation catheters to treat blockages in the lower extremities and vascular stents to open blocked kidney and carotid arteries. In addition,
is evaluating its innovative bioresorbable technology for the treatment of PAD in two international clinical trials: ABSORB BTK and ESPRIT I.
About PAD and Iliac Artery Disease
Peripheral artery disease (PAD) affects approximately 8 million to 12 million people in the U.S.(1) and occurs when the blood vessels outside of the heart become narrowed with plaque, fatty deposits that build up within the vessels. 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.