FDA Advisory Committee Votes Favorably on Expanding the Indication for Abbott's Carotid Stent System to Include Patients at Standard Surgical Risk

By Abbott, PRNE
Tuesday, January 25, 2011

ABBOTT PARK, Illinois, January 26, 2011 - Abbott (NYSE: ABT) today announced that the U.S. Food and Drug
Administration (FDA) Circulatory System Devices Panel of the Medical Devices
Advisory Committee voted that, for symptomatic and asymptomatic carotid
artery disease patients at standard surgical risk, there is reasonable
assurance that the benefits of the RX ACCULINK(R) Carotid Stent System
outweigh its risks (Yes: 7, No: 3, Abstain: 1). Currently, RX ACCULINK is
approved for the treatment of symptomatic and asymptomatic patients at high
risk of adverse events from carotid endarterectomy (surgery). The FDA will
take into account the panel's advice in making its decision on whether to
expand RX ACCULINK's current indication to include patients at standard
surgical risk; the company expects a decision later this year.

"After a thorough review of the scientific evidence, we are pleased that
the advisory committee concluded that less-invasive carotid artery stenting
is as safe and effective as surgery for patients at standard surgical risk,"
said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president,
Medical Affairs, and chief medical officer, Abbott Vascular. "If the FDA
approves an expanded indication, carotid artery stenting would represent an
important additional option for physicians as they work with their patients
to determine the best individualized treatment approach."

The committee's recommendation followed a review of data from CREST
(Carotid Revascularization Endarterectomy vs. Stenting Trial), the largest
prospective study conducted to date comparing stenting to surgery. CREST
demonstrated that carotid artery stenting and carotid surgery had similar
safety and long-term outcomes for patients with symptomatic and asymptomatic
carotid artery disease who were at standard surgical risk. In an analysis of
2,307 standard-risk patients with symptomatic and asymptomatic disease,
carotid artery stenting demonstrated non-inferiority to surgery for the
primary composite endpoint of death, any stroke and myocardial infarction
(heart attack) within 30 days of the procedure plus ipsilateral (same side)
stroke from 31 to 365 days. The results showed 7.1 percent of stenting
patients and 6.6 percent of surgery patients experienced an event, the
difference being non-significant.

About RX ACCULINK Carotid Stent System

The RX ACCULINK Carotid Stent System, used in conjunction with the RX
ACCUNET(R) Embolic Protection System, is indicated for the treatment of
patients at high risk of adverse events from carotid endarterectomy who
require carotid revascularization and meet certain criteria. Additional
information about the RX ACCULINK carotid stent system, including important
safety information, is available online at

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with
market-leading products and an industry-leading pipeline. Abbott Vascular
offers a comprehensive cardiac and vascular devices portfolio, 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 90,000 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.

Media, Jonathon Hamilton, +1-408-624-0314, or Kathleen Rinehart, +1-408-845-1663, or Financial, Larry Peepo, +1-847-935-6722, or Tina Ventura, +1-847-935-9390, all of Abbott

FDA Approval News

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