Abbott Announces Launch Of Next Generation Embolic Protection System

Main Category: Stroke
Also Included In: Vascular;  Clinical Trials / Drug Trials
Article Date: 16 Jun 2009 - 3:00 PDT

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Abbott announced the launch of the sixth-generation Emboshield NAV6™ Embolic Protection System for use in carotid artery stenting procedures. Carotid artery stenting provides a minimally invasive treatment alternative to conventional open carotid artery surgery for patients who are at high risk for surgery. Embolic protection systems are used during the stenting procedure to prevent particles of dislodged plaque from flowing to the brain, potentially causing an ischemic stroke. The Emboshield NAV6 is now available in the United States and Europe.

The Emboshield NAV6 builds upon the strong heritage of the Emboshield® product family, while improving deliverability and ease of use for physicians. Abbott's proprietary BareWire™ technology allows for wire movement independent of the Emboshield NAV6 filter, giving physicians an increased level of control during carotid stenting procedures.

"The innovative design of the Emboshield NAV6 offers marked improvements to an already good embolic protection system. It provides excellent steerable wire options to independently reach challenging lesions, a short basket length, significantly improved visibility, an easier-to-use retrieval system, and optimal pore size and distribution," said D. Christopher Metzger, M.D., FACC, of the Holston Valley Medical Center, Kingsport, Tenn. "These improvements make the NAV6 system an outstanding embolic protection device."

Safety and efficacy endpoints for the Emboshield NAV6 were met in Abbott's PROTECT clinical trial, which was designed to examine carotid artery stenting with Abbott's Emboshield systems in patients at high risk for endarterectomy (surgery). In addition to demonstrating continued improvements in outcomes for carotid stent procedures, the PROTECT study data showed a low 1.8 percent composite rate of All Stroke and Death at 30 days in 220 patients. This rate is well within American Heart Association (AHA) 30-day All Stroke and Death rate guidelines for carotid endarterectomy of 6 percent for symptomatic and 3 percent for asymptomatic patients with carotid artery disease. The PROTECT study results were presented at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C., in October 2008.

"As a member of the PROTECT multispecialty Executive Committee, I have been impressed with the continuing downward trend in stroke rates with protected carotid stenting for patients at high risk for carotid endarterectomy from the earliest clinical trials with first-generation devices 10 years ago," said Jon S. Matsumura, M.D., professor of surgery, University of Wisconsin School of Medicine and Public Health. "These results are related to several factors, including process of care improvements that skilled physicians are developing, and to the continuing improvements in device technology. Abbott's PROTECT study represents state-of-the-art skills and technology for carotid artery stenting."

"Abbott is the worldwide market leader in carotid artery stenting. Since the first carotid stent approval in 1999, more than 100,000 patients have been treated with Abbott's carotid stents and embolic protection systems throughout the world," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The innovative Emboshield NAV6 is an important addition to our portfolio of solutions for treating carotid artery disease, which is a leading cause of stroke."

Abbott has developed a broad portfolio of technologies to help physicians provide better treatment for their patients with peripheral artery disease. The company is committed to making investments in endovascular therapies and educational programs and to designing and conducting endovascular clinical trials.

Abbott's Clinical Program and Leadership in Carotid Clinical Studies

Abbott is the worldwide market leader in carotid artery stenting technology. The Abbott carotid product portfolio provides physicians with multiple carotid stent and embolic protection options: the ACCULINK® and the XACT™ Carotid Stent Systems, and the ACCUNET™ and EMBOSHIELD® family of embolic protection systems.

Abbott has the most comprehensive clinical trial programs in studying the benefits of minimally invasive carotid artery stenting. To date, more than 16,000 patients have been enrolled in nine clinical trials evaluating Abbott's carotid stent systems. These include CREST and ACT I, which are randomized, controlled trials designed to understand the benefits of carotid artery stenting in patients at normal risk for surgery; ARCHeR and SECuRITY trials for U.S. Food and Drug Administration (FDA) device approval; and EXACT, CAPTURE, CAPTURE 2 and CHOICE, post-market studies designed to gather real-world clinical information about carotid artery stenting patients.

A March 6, 2009, publication in Circulation: Cardiovascular Interventions, a peer-reviewed journal of the AHA, examines 30-day outcomes from the EXACT and CAPTURE 2 clinical studies. The article concludes that outcomes for carotid artery stenting using Abbott's devices in high-surgical-risk patients under the age of 80 achieved AHA standards in both symptomatic and asymptomatic lesions.

About Carotid Artery Disease and Carotid Stenting

Approximately 25 percent of strokes are caused by carotid artery disease. In carotid artery disease, arteries located on either side of the neck that supply blood to the brain become narrowed or blocked due to the deposit of fatty plaques that can lead to stroke. Stroke is the third leading cause of death in developed countries, exceeded only by heart disease and cancer1.

The traditional surgical treatment for carotid artery disease usually entails general anesthesia and involves an incision in the patient's neck and artery to remove plaque from inside the vessel wall. Carotid artery stenting is a minimally invasive treatment option. During a carotid stenting procedure, an embolic protection system and stent are deployed using a catheter inserted into a small puncture in an artery in the patient's groin area. The patient usually remains conscious while the stent is implanted at the site of the blockage. The stent remains in place, propping open the carotid artery and restoring normal blood flow to the brain. Most patients return home the day after the carotid stenting procedure.

About Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.

About Abbott

Abbott (NYSE: ABT) 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 more than 72,000 people and markets its products in more than 130 countries.

Source: Abbott