Navigation Links
Abbott's Absolute Pro® Vascular Self-Expanding Stent System Receives FDA Approval for Treatment of Iliac Artery Disease
Date:3/7/2012

ABBOTT PARK, Ill., 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 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, iliac 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.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 91,000 people and markets its products in more than 130 countries.  

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

(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


'/>"/>
SOURCE Abbott
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Published Study Demonstrates the Absolute and Trend Accuracy of Masimo Noninvasive and Continuous Total Hemoglobin (SpHb) Monitoring in Intensive Care Unit Patients
2. Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk
3. Leading Cardiovascular Organizations Release Credentialing Recommendations for Heart Valve Replacement Procedure
4. MarketsandMarkets: Global Peripheral Vascular & Interventional Cardiology Devices Market worth $37.9 Billion by 2016
5. U.S. FDA Grants Priority Review for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
6. AccessClosure, Inc. Launches MynxGrip™ Vascular Closure Device
7. Terumo Cardiovascular Systems Becomes Exclusive U.S. Distributor for TigerPaw® System II, Left Atrial Appendage Closure Device
8. BridgePoint Medical Announces Licensing Agreement for its Peripheral Vascular Products
9. Journal of Cardiovascular Electrophysiology Study Shows Promising Single Ablation Procedure Outcomes With HeartLight EAS for Treatment of Atrial Fibrillation
10. FDA Expands Use of Endovascular Graft to Treat Aortic Tears
11. Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016 , , , ... 7, 2016 , , , , LOCATION: , , , ... , , , EXPERT PANELISTS:  , , , Frost & Sullivan,s ... Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program ... global pharmaceutical industry is witnessing an exceptional era. Several new demand ...
(Date:6/23/2016)... 2016 The vast majority of dialysis patients ... Treatments are usually 3 times a week, with treatment ... travel time, equipment preparation and wait time.  This regimen ... for patients who are elderly and frail.  Many elderly ... rehabilitation centers for some duration of time. ...
(Date:6/23/2016)... 23, 2016 Leading BioSciences Inc., a ... conditions resulting from a breakdown of the mucosal ... Greg Doyle as chief executive officer. Mr. ... management team and board of directors, previously served ... He will provide continued leadership and strategic direction ...
Breaking Medicine Technology:
(Date:6/24/2016)... D.C. (PRWEB) , ... June 24, 2016 , ... ... Heroes Golf Classic Tournament held on June 20th at the Woodmont Country Club ... charity, Luke’s Wings, an organization dedicated to helping service members that have been wounded ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the upcoming 2016 Miss Arizona pageant as its official Medspa Sponsor. Dr. Josh ... Mesa, and Chandler, Arizona. , Dr. Olson says the decision to support ...
(Date:6/24/2016)... ... June 24, 2016 , ... To succeed under ... providers, however, are unsure how to move forward, given the need to sustain ... path forward tailored to an organization’s specific needs. , PYA Principal Martie Ross ...
(Date:6/24/2016)... ... 2016 , ... Today, InhaleLabs.com (Inhale) offilially launched its site, which ... users with high quality water pipes within an ideal price range. The site is ... founded by two brothers, Nick and Mike Hunter, who use medical cannabis to heal ...
(Date:6/24/2016)... ... ... Dr. Seema Daulat, a native Texan and University of Texas at Austin magna ... 13, 2016. , Dr. Daulat earned her Doctorate of Medicine (MD) at The University ... Agape Clinic serving Dallas’ underprivileged community. , Following medical school, Dr. Daulat completed both ...
Breaking Medicine News(10 mins):