Abbott’s Absolute Pro® Vascular Stent Receives FDA Approval For Iliac Artery Disease

In short

Abbott has announced FDA clearance for its 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.

Background

Peripheral artery disease is thought to affect 8 to 12 million people in the U.S. and occurs when the blood vessels outside of the heart become narrowed with plaque, fatty deposits that build up within the vessels. While it 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. Over time, iliac artery disease can progress to a state in which sufferers have reduced walking ability, experience chronic pain and suffer permanent disability.

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.

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.

Clinician comments 

“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.”

Company comments

“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.”

Source: Abbott