Abbott Receives CE Mark for Company's Next-Generation XIENCE PRIME(TM) Drug Eluting Stent, Advancing Leadership Position
23 Juin 2009 - 2:00PM
PR Newswire (US)
Broad Size Matrix of XIENCE PRIME to be Launched in Europe in the
Third Quarter ABBOTT PARK, Ill., June 23 /PRNewswire-FirstCall/ --
Abbott announced today that it has received CE Mark (Conformite
Europeenne) for its next-generation XIENCE PRIME(TM) Everolimus
Eluting Coronary Stent System for the treatment of coronary artery
disease. The company plans to launch XIENCE PRIME in a broad size
matrix with lengths up to 38 mm in Europe in the third quarter.
"XIENCE PRIME leverages and will build upon the outstanding body of
clinical evidence from the SPIRIT family of clinical trials. The
modified design features of the stent and delivery system are
intended to make it easier for physicians to deliver the stent to
the treatment area," said Robert Hance, senior vice president,
vascular, Abbott. "As part of Abbott's leadership in drug eluting
stents, we are committed to advancing treatment options and look
forward to making the innovative XIENCE PRIME stent available to
physicians and patients in Europe in the upcoming months." XIENCE
PRIME utilizes the same well-studied drug and proven biocompatible
polymer as Abbott's market-leading XIENCE V(R) 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(R) 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. Upon launch in Europe, XIENCE PRIME will be
available in an expanded size matrix, including XIENCE PRIME SV for
small vessels and XIENCE PRIME LL for long lesions. 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(TM) Coronary Stent
System, a next-generation frontline balloon dilatation catheter, a
fully bioabsorbable drug eluting coronary device, and the Omnilink
Elite(TM) 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
http://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 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.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com/. DATASOURCE: Abbott
CONTACT: Media, Jonathon Hamilton, +1-408-845-3491, or Jennie Kim,
+1-408-845-1755, or Financial, John Thomas, +1-847-938-2655, or
Tina Ventura, +1-847-935-9390, all of Abbott Web Site:
http://www.abbott.com/
Copyright