The US Food and Drug Administration (FDA) has approved Abbott's Absolute Pro vascular self-expanding stent system, intended for the treatment of iliac artery disease, a form of peripheral artery disease (PAD) which affects the lower extremities.
Absolute Pro is a self-expanding nitinol stent system consisting of a flexible material, indicated for the treatment of patients with de novo or atherosclerotic lesions in the native common iliac artery and native external iliac artery.
The stent incorporates advanced technologies for optimal stent visibility, with a delivery system to minimise friction during stent deployment and ensure precise stent placement at the lesion site.
The approval is backed 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.
The Mobility trial is a prospective non-randomised two-arm multicentre study that evaluated two Abbott stents, Absolute Pro and Omnilink Elite, in patients with iliac artery disease. In the study, Absolute Pro met its primary endpoint, with a nine-month major adverse event rate of 6.1%, significantly lower than the 19.5% performance goal.
Presbyterian Heart Institute in Dallas, US, Peripheral Vascular Interventions, Cardiology Section director and co-principal investigator of the Mobility trial Tony Das said the aim 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 further.
"With Absolute Pro, US physicians now have an additional option that is proven safe and effective to treat many patients with this debilitating disease," Das added.
Abbott Vascular chief medical officer and Medical Affairs divisional vice president Charles Simonton said in the difficult-to-treat population, Absolute Pro demonstrated positive clinical results, including improvement in overall quality of life in 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," Simonton added.
Image: Abbott's Absolute Pro vascular self-expanding stent system has been cleared by FDA. Photo: FDA.