Abbott Announces 30-Day Results of Clinical Trial For Carotid Artery Stent and Filter System
Trial Studied Minimally Invasive Treatment Option for Carotid Artery
Disease in High-Risk Patients
Abbott Park, Illinois, September 19, 2003 — Abbott Laboratories today announced the preliminary results from its SECuRITY trial, a registry of high-risk patients utilizing the MedNova EmboShield® bare-wire filter and MedNova Xact® self-expanding carotid stent system. The trial was designed to evaluate the safety and efficacy of the filter-stent combination as a minimally invasive option for treating carotid artery disease in patients considered at high risk for surgery.
"The early SECuRITY data are very encouraging," said Patrick Whitlow, M.D., director, interventional cardiology, department of cardiovascular medicine, The Cleveland Clinic Foundation, and SECuRITY's principal investigator. "Many patients with carotid disease do not respond well to either of the two current treatment options – drug therapy or high-risk surgery. Based on this early data, we anticipate being able to offer patients a minimally invasive, effective alternative."
The adjudicated 30-day findings were presented September 17 in a "late breaker" session at the annual meeting of Transcatheter Cardiovascular Therapeutics (TCT) in Washington, D.C. The results showed that the study population's major adverse event (MAE) rate was 7.2 percent. For this study, an MAE was defined as a stroke, death or myocardial infarction. The success of the Xact carotid stent (96%) was defined as successful deployment of the stent with less than 50 percent residual stenosis, while the success of the EmboShield device (97.3%) was defined by the successful delivery and removal of the filter. In the trial, all patients had at least one factor that made them high risk for the surgical procedure. Moreover, 28.2 percent of the registry's patients were 80 years or older.
The SECuRITY trial was a prospective, multi-center registry that reported on 305 high-risk patients at 30 sites. Patients were treated with the EmboShield bare wire filter and the Xact carotid stent, both of which were developed by MedNova Limited of Ireland. Abbott Vascular Devices, Abbott's cardiovascular device franchise, sponsored the trial and has an exclusive agreement with MedNova to distribute its EmboShield filter and Xact carotid stent products.
"These promising results indicate that we may be one step closer to our goal of bringing a minimally invasive option to patients considered to be at high risk for surgery," said Donald E. Schwarten, M.D., divisional vice president and medical director, Abbott Vascular Devices. "The EmboShield embolic protection filter and the Xact carotid stent may have the potential to change the way physicians approach and treat patients with carotid artery disease."
Treatment options currently available for carotid artery disease include medication, which clinical studies have shown to be less effective than the surgical procedure called carotid endarterectomy. This procedure involves the surgical removal of plaque build-up from the walls of the carotid arteries and is not easily tolerated by high-risk patients, a group that comprises 15 to 20 percent of patients who experience carotid artery disease.
Patients with carotid artery disease are at particularly high risk for stroke. According to the American Heart Association, stroke is the third most common cause of death in the United States and the leading cause of serious, long-term disability. More than 700,000 new and recurrent cases of stroke are reported each year, with an estimated 20 to 30 percent of cases caused by carotid disease. In these patients, atherosclerotic plaque builds up in the walls of the arteries. This material can cause a stroke if it breaks off from the artery wall, travels through the bloodstream and occludes vessels in the brain, or if the plaque leads to occlusion of the carotid artery.
"The use of bare wire technology to primarily cross the lesion and properly position the EmboShield represents the leading-edge filter technology for use in carotid stenting," noted Jiri Vitek,M.D., Ph.D., Lenox Hill Heart and Vascular Institute, New York, N.Y. "The EmboShield embolic protection system could have a significant impact for many patients for whom surgery would present high risk."
About the EmboShield Distal Protection Device and Xact Carotid Stent
The EmboShield filter is the only filter designed to travel over a bare guidewire for placement just beyond the vessel target lesion. The Xact carotid stent was developed in both straight and tapered designs in order to best fit the carotid anatomy. Once the target lesion is stented, the filter is removed, along with the debris collected, using the filter retrieval catheter.
The EmboShield filter represents MedNova's third-generation filter-based embolic protection device. The EmboShield device and Xact carotid stent are currently distributed by Abbott throughout Europe. Abbott also markets the products in Canada, Latin America, Africa, Asia Pacific and the Middle East. In addition to the SECuRITY trial, the EmboShield filter is currently under investigation in a global, randomized control trial called CAPTIVE, which is studying the efficacy of the EmboShield filter in saphenous vein grafts.
About MedNova
MedNova Limited is a development-stage medical device company. The company, based in Galway, Ireland, is engaged in the development of less invasive products for the treatment of cardiovascular and cerebral vascular disease. The company is at the forefront in the development of intravascular filtration systems designed specifically to improve the results of interventional procedures.
About Abbott Vascular Devices
Abbott Vascular Devices, Abbott's vascular device
franchise, headquartered in Redwood City, Calif., is a medical technology pioneer
that combines Abbott's pharmaceutical and device heritage to deliver specialized
treatment options that dramatically improve the care of people with vascular
disease. Abbott Vascular Devices brings the best of these backgrounds together
to develop unique vessel closure, coronary stent, and peripheral and embolic
protection technologies that meet the specialized needs of vascular disease treatment.
About Abbott Laboratories
Abbott Laboratories is a global, broad-based health
care company devoted to the discovery, development, manufacture and marketing
of pharmaceuticals, nutritionals, and medical products, including devices and
diagnostics. The company employs more than 70,000 people and markets its products
in more than 130 countries. In 2002, the company's sales were $17.7 billion.
Xact and EmboShield are registered trademarks of MedNova Limited.
Private Securities Litigation Reform Act of 1995
A Caution Concerning Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Exhibit 99.1 of our Securities and Exchange Commission Form 10-Q for the period ended June 30, 2003, and are incorporated by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
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