Abbott Receives U.S. FDA Approval for XIENCE nano(TM) to Treat Coronary Artery Disease in Small VesselsBy Abbott, PRNE
Monday, May 23, 2011
ABBOTT PARK, Illinois, May 24, 2011 -
- Abbott Now Offers a 2.25 mm Version of the Market-Leading XIENCE V(R)
Drug Eluting Stent, Which Has Been Studied in More Than 30,000 Patients
Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug
Administration (FDA) approval for the XIENCE nano(TM) Everolimus Eluting
Coronary Stent System for the treatment of coronary artery disease in small
vessels. XIENCE nano, which is based on the same platform as the XIENCE V(R)
Everolimus Eluting Coronary Stent System, offers physicians in the United
States a new option for treating patients with coronary artery disease in
vessels as small as 2.25 mm in diameter.
"The treatment of small vessels is often complex and associated with
higher rates of complications compared to larger vessels," said Marco Costa,
M.D., Ph.D., professor of medicine, director of the Interventional
Cardiovascular 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, Cleveland,
Ohio, and principal investigator of the SPIRIT Small Vessel clinical trial.
"I am confident that the highly deliverable XIENCE nano stent, with its thin
struts and effective everolimus-eluting platform, will help physicians treat
their patients who have coronary artery disease in small vessels."
FDA approval of XIENCE nano was supported by results from the SPIRIT
Small Vessel clinical trial, which showed very low late loss (a measure of
vessel re-narrowing) of 0.20 mm and a target lesion failure (TLF) rate of 8.1
percent, which is comparable to results observed in the SPIRIT clinical
trials with XIENCE V. TLF is defined as a composite measure of important
efficacy and safety outcomes for patients and includes cardiac death, heart
attack attributed to the target vessel (target vessel myocardial infarction),
and ischemia-driven target lesion revascularization (TLR).
Small vessels often are associated with increased levels of restenosis,
or tissue re-growth, following a stent implantation. With its cobalt chromium
stent design, high deliverability, and everolimus drug coating used to
prevent abnormal tissue growth, XIENCE nano is designed to be an optimized
treatment for coronary artery disease in patients who have small vessels.
"As a global leader in vascular care, we are pleased to build upon our
XIENCE franchise with the launch of XIENCE nano in the United States -
expanding the treatment options for the approximately 10 percent of
procedures that utilize a 2.25 millimeter stent," said Robert Hance, senior
vice president, vascular, Abbott. "XIENCE nano leverages the positive safety
and efficacy clinical results consistently demonstrated with XIENCE V, which
has become the leading drug eluting stent platform worldwide. The
introduction of XIENCE nano reinforces our commitment to extending the
innovations we bring to physicians for their patients."
The XIENCE family of drug eluting stents is now available in the United
States in a comprehensive range of diameters from 2.25 mm to 4.0 mm. XIENCE
nano features thin struts measuring 0.0032".
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
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 2.25
mm to 4.25 mm. Additional information about XIENCE V, including important
safety information, is available at
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.
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
Abbott information is available on the company's Web site at
Media, Jonathon Hamilton, +1-408-845-3491, or Kathleen Rinehart, +1-408-845-1663, or Financial:, Larry Peepo, +1-847-935-6722, or Tina Ventura, +1-847-935-9390, all of Abbott
Tags: Abbott, Abbott park, Illinois, May 24