Press Release
Abbott Announces Launch of Next-Generation Embolic Protection System
Emboshield NAV6™ Demonstrates Abbott's Continued Leadership in
Carotid Therapy
June 12, 2009
Abbott Park, Illinois (NYSE: ABT)
— Abbott today 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.
For images of Abbott's carotid stent and embolic protection systems and
other information, please visit www.carotidmediakit.com.
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.
Media:
Jonathon Hamilton
Jennie Kim |
(408) 845-3491
(408) 845-1755 |
Financial:
Tina Ventura |
(847) 935-9390 |
