Press Release
Abbott Initiates Trial of Next-Generation XIENCE PRIME™ Drug Eluting Stent, Building Upon Superior Outcomes from SPIRIT Family of Trials
Company Enrolls First Patient into SPIRIT PRIME Trial in the United
States
June 16, 2009
Abbott Park, Illinois (NYSE: ABT)
— Abbott today announced the initiation of SPIRIT PRIME, a clinical trial to
study the performance of the company's next-generation XIENCE PRIME™ Everolimus
Eluting Coronary Stent System, currently an investigational device, for the
treatment of coronary artery disease. Results from SPIRIT PRIME will be used to
support the regulatory filing for XIENCE PRIME in the United States. The first
patient was enrolled into the SPIRIT PRIME clinical trial at Hillcrest Medical
Center in Tulsa, Okla., by Rajesh Chandwaney, M.D.
XIENCE PRIME utilizes the same well-studied drug and proven biocompatible
polymer as Abbott's market-leading XIENCE V®
Everolimus Eluting Coronary Stent System. In addition, it offers a novel stent
design and a modified delivery system designed for greater flexibility and
improved deliverability. XIENCE PRIME uses cobalt chromium technology, which
allows for very thin struts while maintaining strength to support the vessel as
well as excellent visibility under X-ray during the stent implantation
procedure. XIENCE PRIME is based upon the proven design of the MULTI-LINK®
family of stents, which is the most widely used stent platform in the world –
with more than 2 million implants worldwide. The company expects to launch
XIENCE PRIME in a broad size matrix with sizes up to 38
mm in Europe later this year.
"XIENCE PRIME carries the same successful drug and polymer as the XIENCE V stent. Its stent platform and delivery balloon
are designed to be highly deliverable, and as such, XIENCE PRIME has the
potential to simplify procedures in challenging cases," said Marco A.
Costa, M.D., Ph.D., FACC, FSCAI, professor of medicine, director of the
Interventional Cardiology Center, and director of the Center for Research and
Innovation, Harrington-McLaughlin Heart and Vascular Institute, University
Hospitals Case Medical Center, Case Western Reserve University in Cleveland,
Ohio, and principal investigator of the SPIRIT PRIME trial. "XIENCE V is used routinely in my practice, and I
look forward to studying the enhanced features and sizes of Abbott's
next-generation drug eluting stent, XIENCE PRIME."
The SPIRIT PRIME study is a prospective, multi-center, nonrandomized trial
designed to study XIENCE PRIME in 500 patients at 75 hospital centers. Patients
may receive a maximum of two stents in separate vessels. SPIRIT PRIME will have
two arms: the Core Size arm will follow 400 patients who will be treated with a
stent from 2.25 mm to 4.0
mm in diameter and from 8 mm to 28 mm in length, and the Long Lesion arm will follow
100 patients who will receive a stent from 2.5 mm
to 4.0 mm in diameter and either 33 mm or 38 mm in length.
The primary endpoint is major adverse cardiac events (MACE), which is a
composite measure of cardiac death, heart attack (myocardial infarction) and
repeat procedure of the treated lesion (target lesion revascularization) at one
year.
"Based upon the market-leading technology of XIENCE V, XIENCE PRIME will be available in a greater
breadth of sizes, and is designed to provide improved deliverability," said
Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical
Affairs, and chief medical officer, Abbott Vascular. "SPIRIT PRIME is
expected to build upon the superior outcomes from the SPIRIT family of clinical
trials, and the initiation of the study represents Abbott's commitment to
bringing important advances in drug eluting stent technology to clinicians and
their patients."
In the SPIRIT family of trials, XIENCE V demonstrated superiority to Boston
Scientific's TAXUS® Paclitaxel Eluting Coronary Stent System in two randomized
clinical trials. In the SPIRIT II trial, XIENCE V demonstrated a statistically
significant 69 percent reduction of in-stent late
loss (a measure of vessel re-narrowing) at six months compared to TAXUS. In the
SPIRIT III trial, XIENCE
V demonstrated a statistically significant 50
percent reduction of in-segment late loss (a measure of vessel
re-narrowing) at eight months compared to TAXUS. Long-term results further
reinforce the excellent clinical outcomes, with XIENCE V demonstrating an 88 percent reduction in cardiac death and a 57 percent reduction in MACE compared to TAXUS at three
years in the SPIRIT II trial. At two years in the
SPIRIT III trial, XIENCE
V demonstrated a 45 percent reduction in
the risk of MACE compared to TAXUS. Across the SPIRIT family of trials, Abbott
plans to study more than 20,500 patients treated with everolimus eluting
stents.
In addition to SPIRIT PRIME, Abbott's robust vascular research program
includes clinical trials in coronary artery disease and peripheral artery
disease. Key products in the vascular pipeline include: the MULTI-LINK 8™ Coronary Stent System, a next-generation
frontline balloon dilatation catheter, a fully bioabsorbable drug eluting
coronary device, and the Omnilink Elite™ Peripheral Stent System.
The MULTI-LINK 8 Coronary Stent System, the next-generation frontline
balloon dilatation catheter, the fully bioabsorbable drug eluting device and
the Omnilink Elite Peripheral Stent System are in development and are not
available for sale.
XIENCE PRIME currently is an investigational device in the United States and
not available for sale.
About XIENCE V
Abbott's market-leading XIENCE V drug eluting stent is marketed in the
United States, Europe and other international markets. XIENCE V is an investigational device in Japan and is
currently under review by Japan's Ministry of Health, Labour and Welfare and
the Pharmaceuticals and Medical Devices Agency.
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.
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
72,000 people and markets its products in more than 130 countries.
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