Abbott
announced that the U.S. Food and Drug Administration (FDA) approved the
XIENCE(TM) V Everolimus Eluting Coronary Stent System for the treatment of
coronary artery disease. XIENCE V is the only drug eluting stent to have
demonstrated superiority over Boston Scientific's TAXUS(R)
paclitaxel-eluting coronary stent system in two randomized head-to-head
clinical trials. XIENCE V will be launched in the United States
immediately.
"XIENCE V represents an important treatment advance for the estimated
13 million people in the United States suffering from coronary artery
disease, and we believe XIENCE V will quickly become the new standard for
drug eluting stents given its outstanding clinical results," said John M.
Capek, Ph.D., executive vice president, Medical Devices, Abbott.
"Physicians in the United States have been waiting for years to treat their
patients with a technology that delivers on the promise of drug eluting
stents through both ease of use and excellent clinical performance, and
XIENCE V is that technology."
The XIENCE V drug coated stent is used to treat coronary artery disease
by propping open a narrowed or blocked artery and releasing the drug,
everolimus, in a controlled manner to prevent the artery from becoming
blocked again following a stent procedure. Coronary artery disease occurs
when plaque build- up narrows the arteries and reduces blood flow to the
heart, which can lead to chest pain or a heart attack.
"XIENCE V was designed to improve safety and efficacy compared to
earlier generation stents. The long-term clinical data from two studies
performed in both the United States and Europe have now confirmed that
XIENCE V is a true next-generation drug eluting stent with clinically
important benefits for patients," said Gregg W. Stone, M.D., Columbia
University Medical Center; chairman, Cardiovascular Research Foundation,
New York; and principal investigator of the SPIRIT III U.S. pivotal
clinical trial for XIENCE V.
Clinical Data Supporting XIENCE V
The robust clinical program for XIENCE V includes long-term data from a
total of 1,362 patients enrolled in the SPIRIT FIRST, SPIRIT II and SPIRIT
III trials, as well as continued access and post-approval programs that
will enroll more than 14,000 XIENCE V patients.
The FDA approved XIENCE V based, in large part, on superior results
from the 1,002 patient SPIRIT III U.S. pivotal clinical trial, in which
XIENCE V demonstrated statistical superiority to TAXUS on the study's
primary endpoint of in-segment late loss (vessel renarrowing) at eight
months, with a statistically significant 50 percent reduction (mean, 0.14
mm for XIENCE V vs. 0.28 mm for TAXUS). XIENCE V also demonstrated
statistical non-inferiority to TAXUS in the co-primary endpoint of target
vessel failure (TVF, cardiac events related to the stented vessel) at nine
months, with an observed 20 percent reduction (7.2 percent for XIENCE V vs.
9.0 percent for TAXUS). TVF is a composite clinical measure of safety and
efficacy outcomes defined as cardiac death, heart attack (myocardial
infarction or MI) or target vessel revascularization (TVR).
In May 2008, Abbott presented two-year data from the SPIRIT III trial
demonstrating that XIENCE V continues to deliver positive clinical benefits
for patients. At two years, the XIENCE V demonstrated the following key
results:
-- A 45 percent reduction in the risk of major adverse cardiac events
(MACE) compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for
TAXUS, p-value=0.004)*. MACE is an important composite clinical measure of
safety and efficacy outcomes for patients, defined as cardiac death, heart
attack (MI) or ischemia-driven target lesion revascularization (TLR, repeat
procedures driven by lack of blood supply).
-- A 32 percent reduction in the risk of TVF compared to TAXUS (10.7
percent for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04).
-- Low rates of stent thrombosis between one and two years, defined as
very late stent thrombosis, per Academic Research Consortium (ARC)
definition of definite/probable stent thrombosis (0.3 percent for XIENCE V
and 1.0 percent for TAXUS) and per the SPIRIT III protocol (0.2 percent for
XIENCE V and 1.0 percent for TAXUS). The ARC definition of late stent
thrombosis was developed to eliminate variability in the definitions across
various drug eluting stent trials.
"Today's approval of XIENCE V is a reflection of Abbott's ongoing
commitment to bring innovation-driven, leading-edge medical technologies to
the people who need them," added Capek. "With one of the largest, most
seasoned vascular sales forces in the United States and with the ability to
supply more than half the worldwide market, we will begin shipping units of
XIENCE V immediately to meet physician demand for this much awaited, next-
generation technology."
More About XIENCE V
XIENCE V is built upon Abbott's market-leading bare metal stent, the
MULTI-LINK VISION(R) Coronary Stent System. The VISION platform is designed
to facilitate ease of delivery, making it easier for physicians to maneuver
the stent and treat the diseased portion of the artery.
The XIENCE V drug coated stent will be available on both over-the-wire
(OTW) and rapid exchange (RX) delivery systems. Rapid exchange is the most
widely used type of delivery system because it provides physicians
additional flexibility to work as single operators during stent procedures.
XIENCE V was launched in Europe and other international markets in
October 2006. XIENCE V is an investigational device in Japan and is
currently under review for approval by Japan's Ministry of Health, Labour
and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency
(PMDA).
Abbott also supplies a private-label version of XIENCE V to Boston
Scientific called the PROMUS(TM) Everolimus-Eluting Coronary Stent System.
PROMUS is designed and manufactured by Abbott and supplied to Boston
Scientific as part of a distribution agreement between the two companies.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal
inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its
drug eluting stents. Everolimus has been shown to inhibit in-stent
neointimal growth in the coronary vessels following stent implantation, due
to its antiproliferative properties.
Additional information about XIENCE V, including important safety and
effectiveness information, is available online at xiencev.
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 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 68,000 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 abbott.
Event rates are based on Kaplan-Meier estimates; p-values are for
descriptive purposes only.
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