Absolute Pro® Vascular Self-Expanding Stent System receives FDA approval

Abbott 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 Dallas, Texas, 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 Abbott 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. Abbott’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 Abbott’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, Abbott 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.

Aortoiliac occlusive disease (AIOD), more commonly known as iliac artery disease, occurs when the iliac arteries become narrowed with plaque, resulting in reduced blood flow to the lower limbs. Iliac artery disease is a type of PAD. While PAD refers to all of the arteries outside of the heart, iIiac artery disease refers specifically to the arteries that start in the mid-abdomen – where the body’s main artery (the aorta) splits into branches that descend through the pelvis into the legs.[2] Iliac artery disease is caused by plaque build-up in one or more of these major arteries: the infrarenal aorta, common iliac, internal iliac (hypogastric), and external iliac.

About the Absolute Pro Vascular Stent System

The Absolute Pro Vascular Stent System is indicated for the treatment of patients with de novo or atherosclerotic lesions in the native common iliac artery and native external iliac artery. Specific information about the Absolute Pro Vascular Stent System, including important safety information, is available online at http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/peripheral_intervention/eIFU_Absolute_Pro.pdf.

About Abbott Vascular

Abbott Vascular is the world’s leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.

References

1. Selvin E and Erlinger TP. Circulation. 2004; 110:738-743. Crique, et al. Circulation. 2005; 112:2703-2707.
2. http://www.vascularweb.org/vascularhealth/Pages/aortoiliac-occlusive-disease.aspx