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Abbott Receives U.S. Approval for New Device Designed to Treat Patients at Risk of Stroke
Abbott Is Second to Market With Minimally Invasive Treatment for Carotid Artery Disease -
ABBOTT PARK, Ill., Sept. 15 / -- Abbott (NYSE:ABT) today announced it received U.S. Food and Drug Administration (FDA) approval for a new minimally invasive device to treat patients with carotid artery disease, a risk factor for stroke. Abbott received FDA approval for the Xact(R) Carotid Stent and 510(k) clearance for the Emboshield(R) Embolic Protection System to treat patients at risk of stroke who are not favorable candidates for surgery. With this, Abbott becomes the second company to enter the U.S. carotid stent market.
"Surgery, or carotid endarterectomy, has proven a reliable method for treating carotid artery disease, but it is not the ideal treatment for everyone," said Gary S. Roubin, Ph.D., M.D., chairman of the department of interventional cardiology at Lenox Hill Hospital in New York. "Some patients may stand to benefit more from a minimally invasive procedure with a carotid artery stent and embolic protection that avoids the risk associated with general anesthesia, eliminates the risk of cranial nerve injury and neck scarring. The Xact Carotid Stent and Emboshield Embolic Protection System provide a truly advanced minimally invasive treatment alternative for these patients."
"The launch of our carotid stent system in the United States is further evidence of the innovative line of vascular products Abbott has built that is gaining momentum in the interventional community," said Robert B. Hance, president of Abbott Vascular. "We are delighted to see the benefits of clinical and scientific advancement at Abbott result in an important new treatment for patients at risk of stroke."
The new system features a stent specifically designed to treat diseased carotid arteries -- arteries in the neck that have become clogged or partially blocked due to the build-up of fatty plaque and debris (atherosclerosis). The Xact stent is self-expanding and has a closed-cell design that creates a tightly knit yet highly flexible mesh intended to help restore the inner diameter of a carotid artery, promote a smooth inner vessel surface, and potentially reduce the release of fatty debris (emboli) from a diseased vessel when it is treated, which can lead to stroke.
The Xact stent is designed for use in combination with the fully retractable Emboshield filter. Emboshield is designed to capture emboli that can break off during a carotid stenting procedure, and it is the only filter to feature Barewire(TM), a proprietary technology developed to allow for better control of stent placement once the filter is in place and fully apposed against the vessel wall.
Abbott established an exclusive agreement to market and distribute Emboshield in February 2001 with Mednova Limited in Galway, Ireland, which developed the stent and filter.
Abbott received approval and clearance for the Xact Carotid Stent and Emboshield Embolic Protection System based on its submission of SECuRITY Registry Study data in a Premarket Approval application filed in 2004. Both Emboshield and Xact already have CE Mark approval and were launched in the European Union at the end of 2003.
For important safety information regarding Abbott's Xact Carotid Stent and Emboshield Embolic Protection System, please visit http://www.abbottvascular.com/carotidfb .
About The SECuRITY Registry Study
The SECuRITY Registry Study was a prospective, multi-center, non- randomized trial involving 305 patients from 30 sites in the United States and Australia, designed to demonstrate the safety and effectiveness of the Xact Carotid Stent and Emboshield Embolic Protection System in treating carotid artery disease. One-year findings showed that the Xact Carotid Stent, when used in conjunction with the Emboshield Embolic Protection System, provides a safe, effective and durable method that is comparable to carotid surgery for the treatment of carotid disease in patients deemed too high-risk for carotid endarterectomy (surgery).
First Investigational Study In Asymptomatic Patients Underway
In addition to receiving approval for its new carotid disease treatment system, Abbott is first to investigate the benefits of carotid artery stenting versus carotid artery surgery in the broader asymptomatic patient population - patients without symptoms of stroke who have carotid artery disease and who would otherwise be referred for surgery to treat their condition.
Low-level carotid artery disease without stroke symptoms is common in the general population, but people with a high level (>70 percent stenosis) of carotid artery disease are at an elevated risk of having a stroke.(1) The American Heart Association has estimated that approximately 75 percent of stroke patients do not have symptoms of the disease.(2)
Abbott's ACT I (Asymptomatic Patients with Significant Extracranial Carotid Occlusive Disease Trial) is the first multi-center, randomized trial to compare the safety and effectiveness of carotid artery stenting with carotid artery surgery. Abbott is conducting the ACT I trial with the Xact Carotid Stent and Emboshield Embolic Protection System.
About Stroke and Carotid Artery Disease Treatment
The American Heart Association estimates that 700,000 Americans will suffer a stroke this year and that 88 percent of strokes are ischemic, characterized by a loss of blood supply to the brain.(3) Ischemic attacks are often caused by an embolism, a particle of atherosclerotic (fatty) plaque that breaks off from a diseased vessel and lodges in a smaller vessel, reducing or cutting off the blood supply to the area beyond the blockage. Approximately 30 percent of strokes are caused by embolic events originating from diseased carotid arteries.(4)
The goal of carotid artery disease treatment is to restore adequate blood flow in the region of the artery that is blocked and to stabilize the fatty plaque in order to prevent plaque rupture that can create embolic debris leading to a stroke. Patients with severe carotid blockages have traditionally been treated with carotid endarterectomy, a surgical procedure in which the artery is opened and the plaque is removed.
Surgery can cause complications such as nerve damage and neck scarring. As a result, interventional physicians have started using less-invasive procedures, such as balloon angioplasty and stent placement, to treat carotid artery blockages in patients who are deemed at high risk for developing complications from surgery. Patients who may be too high-risk for carotid surgery include patients with severe coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, previous carotid endarterectomy, radical neck surgery or radiation therapy.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is transforming the treatment of vascular disease, combining the latest medical device innovations with world- class pharmaceuticals to advance medicine and improve patient care. Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety, ease of use and effectiveness in treating patients with vascular disease. Abbott Vascular is headquartered in Redwood City, Calif. For more information about Abbott Vascular, visit http://www.abbottvascular.com/ .
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 more than 60,000 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 http://www.abbott.com/ .
Trademarks
Xact and Emboshield are registered trademarks of Abbott, and Barewire is a trademark of Abbott.
References
(1) Al-Mubarak et al, Carotid Artery Stenting - Current Practice and Techniques, p. 9, Philadelphia, PA, Lippincott Williams & Wilkins, c. 2004.
(2) Heart Disease and Stroke Statistics - 2004 Update, Dallas, TX: American Heart Association. 2003:1-52.
(3) Heart Disease and Stroke Statistics - 2005 Update, American Heart Association
(4) Al-Mubarak et al, Carotid Artery Stenting - Current Practice and Techniques, p. 48, Philadelphia, PA, Lippincott Williams & Wilkins, c. 2004.
Web site: http://www.abbott.com/
http://www.abbottvascular.com/
Company Information:
Name: Abbott Laboratories
Address: 100 Abbott Park Rd., AP Abbott Park 5, Dept. 209
City: Abbott Park
State: IL
ZIP: 60064
Country: USA
Phone: 847-937-6578
FAX: 847-937-1708
http://www.abbott.com/
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