Abbott to Present Data on Market-Leading XIENCE V(R) and Promising Vascular Pipeline at TCT 2010
By Abbott, PRNEWednesday, September 15, 2010
ABBOTT PARK, Illinois, September 16, 2010 - — XIENCE V Data From the SPIRIT IV Trial to be Presented as a Late
Breaking Trial on Sept. 23
— Abbott's Vascular Pipeline Presentations to Include Data on the
MitraClip(R) System and the Bioresorbable Vascular Scaffold
Abbott (NYSE: ABT) today announced the company's schedule of key data
presentations at the Cardiovascular Research Foundation's 22nd annual
Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in
Washington, D.C., to be held Sept. 21 - 25. Highlights include late-breaking
two-year data from SPIRIT IV, one of the largest randomized, head-to-head
clinical trials between two drug eluting stents - Abbott's XIENCE V(R)
Everolimus Eluting Coronary Stent System and Boston Scientific's TAXUS(R)
Express Paclitaxel-Eluting Coronary Stent System. In addition, the company
will present data on two key pipeline products: the first-of-its-kind
MitraClip(R) system, an investigational device in the United States; and the
bioresorbable vascular scaffold (BVS), currently under clinical investigation
outside the United States.
"We continue to strengthen our leadership position in the treatment of
vascular disease with significant new data that support our market-leading
XIENCE V stent, which has become the gold standard of drug eluting stents
around the world," said Robert Hance, senior vice president, vascular,
Abbott. "We also continue to make progress with our industry leading vascular
pipeline, and we look forward to presenting additional data on our key
pipeline products, including the MitraClip system and our bioresorbable
vascular scaffold."
Key presentations are as follows (all times are Eastern):
SPIRIT IV: Two-year results from SPIRIT IV will be presented by Gregg W.
Stone, M.D., professor of medicine at Columbia University Medical Center,
during the first late-breaking clinical trials session at 11 a.m. in the Main
Arena on Thursday, Sept. 23. SPIRIT IV is one of the largest randomized
clinical trials ever conducted that compares two drug eluting stents.
The study enrolled 3,690 patients - including more than 1,000 patients
with diabetes. Dr. Stone is the principal investigator of the SPIRIT IV
trial.
SPIRIT III: Four-year results from SPIRIT III will be presented during
the Scientific Symposia starting at 1 p.m. on Wednesday, Sept. 22. SPIRIT III
is a prospective, multi-center, randomized, single-blind, controlled clinical
trial comparing XIENCE V to TAXUS in 1,002 patients (669 XIENCE V patients
and 333 TAXUS patients) with either one or two de novo coronary artery
lesions.
XIENCE V USA: One-year results from XIENCE V USA, including subset data,
will be presented during the Scientific Symposia starting at 3:30 p.m. on
Wednesday, Sept. 22. XIENCE V USA is a post-market, real-world, single-arm
registry evaluating outcomes in more than 5,000 XIENCE V patients based in
the U.S., with follow-up out to five years. Subset data presented at TCT will
include information on patient quality of life after receiving a XIENCE V
stent and data on the safety and efficacy of XIENCE V in real-world patients
with acute myocardial infarction.
EVEREST II: During the Scientific Symposia starting at 3:30 p.m. on
Wednesday, Sept. 22, a number of presentations will review new data from
EVEREST II, the landmark trial of the MitraClip system, a first-of-its-kind,
catheter-based device for mitral valve repair. In addition, the MitraClip
system will be highlighted during the "Hottest Topic of 2010: Transcatheter
Valve Therapy" session starting at 9:30 a.m. on Thursday, Sept. 23, and the
"Best of the Best TCT 2010 Abstracts" starting at 3:16 p.m. on Friday, Sept.
24. The MitraClip system received CE Mark in March 2008. In the U.S., the
MitraClip system is limited by federal law to investigational use only and is
not available for sale. The MitraClip system is currently under review for
approval by the U.S. Food and Drug Administration.
ABSORB: Nine-month data on 45 patients and six-month data on all 101
patients from the second phase of ABSORB will be presented on Wednesday,
Sept. 22. The ABSORB trial is evaluating Abbott's bioresorbable vascular
scaffold (BVS), which aims to restore blood flow by opening a clogged vessel
and providing support until it is healed. Once the vessel can remain open
without the extra support, the BVS is designed to be slowly metabolized and
eventually resorbed by the body. Abbott's BVS device is under clinical
investigation outside the U.S. The device is currently in development at
Abbott Vascular and not available for sale.
As part of its commitment to ongoing medical education, Abbott is
providing support for a number of symposia on key topics for interventional
cardiologists throughout the conference. In addition, the Abbott booth
(#1456) will feature the company's vascular pipeline, as well as resources
and programs for physicians and patients.
About XIENCE V
Abbott's market-leading XIENCE V drug eluting stent is marketed in the
U.S., Europe, Japan and other international markets.
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
anti-proliferative 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) with reference vessel diameters of 2.5
mm to 4.25 mm. Additional information about XIENCE V, including important
safety information, is available online 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 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, +1-408-845-3491, or Financial, Larry Peepo, +1-847-935-6722, both of Abbott
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