Press Release
Abbott's XIENCE V® Approved in Japan – Second Largest Drug Eluting Stent Market Worldwide
Launch in Japan to Begin Immediately Following Final Reimbursement
Authorization
January 8, 2010
Abbott Park, Illinois (NYSE: ABT)
— Abbott announced today that the Japanese Ministry of Health, Labor and
Welfare (MHLW) has approved its XIENCE V®
Everolimus Eluting Coronary Stent System for the treatment of coronary artery
disease. Japan is the second largest drug eluting stent market in the world
after the United States, with approximately 200,000 stent procedures performed
each year. The company plans to launch XIENCE V
in Japan in the upcoming weeks, immediately following final reimbursement
authorization.
"With today's approval, physicians in Japan will now have access to a
next-generation drug eluting stent that offers outstanding ease of use and
excellent clinical performance and safety. XIENCE
V is the ideal combination as documented by the more than 16,000
patients who have been enrolled in the SPIRIT family of trials," said
Robert Hance, senior vice president, vascular, Abbott. "Each aspect of
XIENCE V's design, from the thin struts to the
flexible delivery system to the drug and polymer, was carefully engineered for
optimal deliverability and to improve safety and efficacy outcomes for patients
compared to earlier generation stents. These attributes have made XIENCE V the market-leading drug eluting stent around
the world, and we look forward to making XIENCE V
available to physicians in Japan shortly."
"XIENCE V is flexible and easy to deliver through the coronary anatomy
to the lesion site. These attributes combined with the strength of the safety
and efficacy data supporting it give me confidence that XIENCE V is a true next-generation stent that has the
potential to benefit heart patients in Japan," said Shigeru Saito, M.D.,
F.A.C.C., F.S.C.A.I., F.J.C.C., director, Cardiology and Catheterization
Laboratories, Shonan Kamakura General Hospital, and principal investigator for
the SPIRIT III Japan Registry.
The outstanding data for XIENCE V includes clinically superior long-term
efficacy and safety results in the primary endpoints of the pivotal trials, and
among the SPIRIT family of trials. The SPIRIT III
Japan Registry of 88 patients demonstrated similar angiographic and clinical
results to the outstanding outcomes from the SPIRIT
III U.S. trial. In the SPIRIT III Japan
Registry, XIENCE V demonstrated a single-digit
rate of major adverse cardiac events (MACE, 8.0
percent), and no cases of stent thrombosis (blood clots) out to one
year. MACE is an important composite clinical measure of safety and efficacy
outcomes for patients and is defined as cardiac death, heart attack (all
myocardial infarction or MI), or ischemia-driven target lesion
revascularization (ID-TLR).
In the SPIRIT III U.S. trial, XIENCE V demonstrated an impressive low rate
of very late stent thrombosis with no additional events between two and three
years, and a 43 percent reduction in the risk of
MACE compared to the TAXUS® Express2 Paclitaxel-Eluting Coronary
Stent System (TAXUS)at three years (9.1 percent for XIENCE V vs. 15.7 percent
for TAXUS, p-value=0.003).
In SPIRIT IV, one of the largest randomized trials comparing two drug
eluting stents, XIENCE V demonstrated a
statistically significant 39 percent reduction in
target lesion failure (TLF) compared to TAXUS at one year (3.9 percent for XIENCE V
vs. 6.6 percent for TAXUS,
p-value=0.0008)1. TLF is a composite measure of important efficacy
and safety outcomes for patients and includes cardiac death, target vessel MI
and ID-TLR. XIENCE V also had an exceptionally
low rate of stent thrombosis out to one year, with a 74
percent reduction in definite/probable stent thrombosis per the Academic
Research Consortium (ARC) definition compared to TAXUS (0.29 percent for XIENCE
V and 1.10 percent for TAXUS,
p-value=0.004).
Additionally, in the investigator-initiated COMPARE trial of real-world
patients, XIENCE V demonstrated significantly better outcomes in key safety and
efficacy measures compared to the TAXUS® Liberte Paclitaxel-Eluting Coronary
Stent System (TAXUS). At one year, XIENCE V
demonstrated a statistically significant 31
percent reduction in MACE compared to TAXUS (6.2
percent XIENCE V vs. 9.1 percent TAXUS, p-value=0.023),2 and a
statistically significant 74 percent reduction in
stent thrombosis compared to TAXUS (0.7 percent
XIENCE V vs. 2.6
percent TAXUS, p-value=0.002)2.In the COMPARE trial, MACE is
defined as all death, non-fatal MI and target vessel revascularization.
More About XIENCE V
Abbott's market-leading XIENCE V 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.
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.
In some geographies, Abbott 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.
XIENCE V is indicated for improving coronary luminal diameter in patients
with symptomatic heart disease due to de novo native coronary artery
lesions (lesions less than or equal to 28 mm).
Additional information about XIENCE V, including
important safety information, is available online in Japanese at www.xiencev.jp, and in English at www.xiencev.com or www.abbottvascular.com/en_US/content/document/eIFU_XienceV.pdf.
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 (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.
| 1 |
Event rates are based on Kaplan-Meier estimates; p-values based on log-rank
test. |
| 2 |
Event rates are based on Kaplan-Meier estimates. |
Media:
Jonathon Hamilton
Jennie Kim |
(408) 845-3491
(408) 845-1755 |
Financial:
John Thomas
Tina Ventura |
(847) 935-9390
(847) 935-9390 |
