Press Release
Abbott's XIENCE PRIME™ and XIENCE V® Receive Indications in Europe for Treatment of Patients with Diabetes
CE Markings for Additional New Indications Further Validate Use of Abbott’s
Drug Eluting Stents in Treating a Range of High-Risk and Complex Patients
BRUSSELS, Belgium, Nov. 2, 2009 — Abbott today announced that both the
XIENCE PRIME™ Everolimus Eluting Coronary Stent System1 and the
XIENCE V® Everolimus Eluting Coronary Stent System have received additional new
CE Markings (Conformité Européenne) covering the treatment of patients with
diabetes. Receiving these new indications among the European Union Member
States validates the use of XIENCE PRIME and XIENCE V to treat patients with
diabetes. Coronary artery disease is one of the most common cardiovascular
complications of diabetes and is the number one cause of death among European
adults with diabetes2.
"This expanded indication further confirms XIENCE PRIME and XIENCE V as
important options for physicians who are treating patients with diabetes,"
said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical
Affairs, and chief medical officer, Abbott Vascular. "Patients with
diabetes tend to be sicker and have more challenging anatomy, such as small
vessels or long lesions, which can be difficult to treat. The deliverability of
both devices provides physicians with confidence to easily reach the lesion
site."
In addition to diabetes, XIENCE PRIME and XIENCE V also received CE Mark for
expanded indications to treat patients that have complex disease, including
dual vessels, small vessels and jailed side branches (small side branches of
less than 2.0 mm in diameter that are covered, or "jailed," when a
larger artery is stented). The expanded indications for XIENCE PRIME and XIENCE
V are based on randomized clinical trial data from the SPIRIT family of trials
that support the safety and performance of the stents in these patient
subgroups. XIENCE PRIME also is indicated for use in long vessels and is
available in stent lengths of 33 mm and 38 mm. Both XIENCE PRIME and XIENCE V
leverage the excellent outcomes from the extensive body of clinical evidence
from the SPIRIT family of clinical trials. Most recently, data from the
company's SPIRIT IV trial comparing XIENCE V to the TAXUS® Express2™
Paclitaxel-Eluting Coronary Stent System were presented at the Transcatheter
Cardiovascular Therapeutics (TCT) annual meeting in September 2009. With 3,690
patients, the SPIRIT IV trial is one of the largest head-to-head randomized
clinical trials between two drug eluting stents and includes more than 1,100
patients with diabetes.
XIENCE PRIME and XIENCE V are based upon the well-tested design utilized in
the MULTI-LINK VISION® family of stents, which is the most widely used stent
platform in the world – more than 2 million of Abbott's cobalt chromium stents
have been implanted worldwide.
XIENCE PRIME received CE Mark in June 2009, and XIENCE V received CE Mark in
2006. XIENCE PRIME is an investigational device in the United States and is not
available for sale in the United States or outside of jurisdictions in which
the product has been CE Marked. These additional indications apply to XIENCE V
exclusively in countries where the product bears a CE Mark.
About Diabetes and Cardiovascular Disease
The high blood glucose levels associated with diabetes can lead to increased
deposits of fatty materials on the insides of the blood vessel walls. These
deposits may affect blood flow to the heart, increasing the chance of clogging
and hardening of blood vessels. Patients with diabetes who also have coronary
artery disease often have poorer outcomes after stent procedures because their
blood vessels tend to build up more plaque than the vessels of non-diabetic
patients, and their coronary artery disease advances more quickly.
About XIENCE PRIME and XIENCE V
XIENCE PRIME is the latest innovation from Abbott's robust vascular research
program and is commercially available in CE Mark countries. XIENCE PRIME offers
a novel stent design and a delivery system designed for greater flexibility and
enhanced deliverability. XIENCE PRIME is available in a broad size matrix,
including XIENCE PRIME SV for small vessels and XIENCE PRIME LL for long
lesions.
Abbott's market-leading XIENCE V drug eluting stent is commercially
available 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.
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
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 PRIME and XIENCE V, including
important safety information, is available online at www.xienceprime.com, www.xiencev.com or www.abbottvascular.com/en_US/content/document/eIFU_XienceV.pdf.
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
72,000 people and markets its products in more than 130 countries.
1 XIENCE PRIME is an investigational device in the United States and
is not available for sale.
2 Ryden L, Standl E, Bartnik M, et al. Guidelines on diabetes,
pre-diabetes, and cardiovascular diseases: executive summary: The Task Force on
Diabetes and Cardiovascular Diseases of the European Society of Cardiology
(ESC) and of the European Association for the Study of Diabetes (EASD). Eur
Heart J 2007;28(1):88-136
