Press Release
FDA Approves Abbott's XIENCE V™ Drug Eluting Stent
XIENCE V, Only Drug Eluting Stent to Demonstrate Superiority Over
Market-Leading Stent in Clinical Trials, Now Available in United States for
Treatment of Coronary Artery Disease
July 2, 2008
Abbott Park, Illinois (NYSE: ABT)
— Abbott today announced that the U.S. Food and Drug Administration (FDA)
approved the XIENCE 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® 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.
| * |
Event rates are based on Kaplan-Meier estimates; p-values are
for descriptive purposes only. |
"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® 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™
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 www.xiencev.com.
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
68,000 people and markets its products in more than 130 countries.
Editor's Note:
Additional background information, including broadcast-quality video, animation
and images, are available to members of the media through the XIENCE V media kit at www.xiencemediakit.com.
Media:
Kelly Morrison
Jonathon Hamilton |
(847) 937-3802
(408) 390-5074 |
Financial:
John Thomas
Larry Peepo |
(847) 938-2655
(847) 935-6722 |
