Navigation Links
Abbott Begins Post-Approval Study of XIENCE V(TM) Drug Eluting Stent

XIENCE V USA Study to Evaluate Treatment of Coronary Artery Disease

Patients in Real-World Setting

ABBOTT PARK, Ill., July 9 /PRNewswire-FirstCall/ -- Abbott today announced the start of the XIENCE V(TM) USA post-approval study, with six hospital centers already recruiting and enrolling patients just one week after the U.S. Food and Drug Administration approved the XIENCE V(TM) Everolimus Eluting Coronary Stent System. The XIENCE V USA study will evaluate the safety and effectiveness of the XIENCE V drug eluting stent in a real-world clinical setting out to five years. Jack Jones, M.D., interventional cardiologist and medical director of the Stormont-Vail Catheterization Lab in Topeka, Kan., was one of the first physicians to enroll a patient into the study.

"XIENCE V is an important innovation that gives patients in the United States access to a next-generation drug eluting stent that has been shown in clinical trials to improve patient outcomes," said Dr. Jones. "During the stent procedure, we found it easy to deliver XIENCE V to the diseased portion of the vessel. With its combination of clinical efficacy and deliverability, I believe that XIENCE V will become a key advancement in the treatment of coronary artery disease."

The XIENCE V USA study is designed to evaluate at least 5,000 coronary artery disease patients treated with the XIENCE V drug eluting stent at approximately 250 centers across the United States. The primary endpoint of XIENCE V USA is a measure of stent thrombosis (formation of blood clots) every year out to five years, as defined by the Dublin/Academic Research Consortium (ARC). The ARC definition of late stent thrombosis was developed to eliminate variability in the definitions across various drug eluting stent trials.

The co-primary endpoint of the study is the composite rate of cardiac death and any heart attack (Q-wave or non-Q-wave myocardial infarction) in patients at one year. Secondary endpoints of the study include patient compliance with prescribed anti-platelet medication, measures of re-treatment by stenting or surgery, and device and procedural success.

"Post-approval studies allow physicians to follow the safety and efficacy of new treatments in a more complex patient population than is typically studied in pre-approval clinical trials. XIENCE V USA will provide significant insight about the performance of Abbott's new drug eluting stent in a variety of patients," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "Our ability to work with our physician partners to begin this post-approval study within days of FDA approval is further evidence of Abbott's commitment to help the interventional cardiology community gain additional insights about the clinical benefits of XIENCE V."


XIENCE V is used to treat coronary artery disease by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner to prevent the artery from becoming blocked again following a stent procedure. XIENCE V is built upon Abbott's market-leading bare metal stent, the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery.

Long-term results with XIENCE V in the SPIRIT III pivotal U.S. clinical trial demonstrated a 45 percent reduction in the risk of major adverse cardiac events (MACE) compared to the TAXUS(R) paclitaxel-eluting coronary stent system at two years. XIENCE V demonstrated a 32 percent reduction in target vessel failure (TVF, cardiac events related to the stented vessel) compared to TAXUS at two years. XIENCE V also demonstrated a low rate of stent thrombosis between one and two years, defined as very late stent thrombosis, per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.3 percent for XIENCE V and 1.0 percent for TAXUS). XIENCE V met its primary endpoint in the SPIRIT III clinical trial with a statistically significant 50 percent reduction in in-segment late loss (vessel renarrowing) at eight months compared to TAXUS.

The XIENCE V stent is available on both over-the-wire (OTW) and rapid exchange (RX) delivery systems. Rapid exchange is the most widely used type of delivery system because it provides physicians additional flexibility to work as single operators during stent procedures.

XIENCE V was approved by the U.S. Food and Drug Administration on July 2, 2008, and was launched in Europe and other international markets in October 2006. XIENCE V is an investigational device in Japan and is currently under review by the 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(TM) 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 antiproliferative properties.

Additional information about XIENCE V, including important safety and effectiveness information, is available online at

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 68,000 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

Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Abbott Named One of the Best Places to Launch a Career by BusinessWeek
2. Martek Signs Multi-Year Worldwide Sole Source Supply Agreement with Abbott
3. Abbott Scientists Create One Molecule With Two Antibody Functions
4. Abbott Named to Science Magazines List of Top Employers in the Biotech and Pharmaceutical Industry
5. Abbotts HUMIRA(R) Receives Positive Opinion From EMEA for Treatment of Moderate to Severe Plaque Psoriasis
6. Abbott Declares 336th Consecutive Quarterly Dividend
7. Pfizer, Genentech, Amgen, Bayer, Wyeth, Abbott, Merck and Additional Leading Pharmaceutical Companies Participating During ExL Pharmas Fall Line Up!
8. Abbott to Present at JP Morgan Healthcare Conference
9. Abbott Announces Approval of First Fully Automated Blood Screening Test for HTLV-I/HTLV-II
10. Isis Announces Equity Investment in Ibis Biosciences Subsidiary by Abbott; Option Acquired to Purchase Remaining Ibis Equity
11. Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management
Post Your Comments:
(Date:11/24/2015)... and NEW YORK , November 24, ... investment by Bristol-Myers Squibb in a European ... Bristol-Myers Squibb Company in which the companies will work ... immuno-oncology and other areas of unmet medical need. The collaboration ... LSP 5, the latest LSP fund. This is the first ...
(Date:11/24/2015)... , Nov. 24, 2015 According to two new ... 2005. This is something that many doctors, scientists, and public ... questions remains: with fewer PSA tests being done, will there ... Dr. David Samadi, "Despite the efforts made ... remains the second leading cancer cause of death in men, ...
(Date:11/23/2015)... Nov. 23, 2015   Ceres, Inc . (Nasdaq: ... financial results for the fiscal year ended August 31, ... --> --> During fiscal ... and feed products with a better balance of yield, ... distribution agreements with several leading crop input providers and ...
(Date:11/23/2015)... Md. (PRWEB) , ... November 23, 2015 , ... ... 100 award for the development of its Nexera UC Unified Chromatography system. The ... 100 most technically significant new products of the year in the analytical and ...
Breaking Biology Technology:
(Date:11/17/2015)... SOUTH EASTON, Mass. , Nov. 17, 2015 /PRNewswire/ ... "Company"), a leader in the development and sale of ... to the worldwide life sciences industry, today announced it ... closing of its $5 million Private Placement (the "Offering"), ... Offering to $4,025,000.  One or more additional closings are ...
(Date:11/11/2015)... , Nov. 11, 2015   MedNet Solutions , an ... of clinical research, is pleased to announce that it will ... Trials (PCT) event, to be held November 17-19 in ... to view live demonstrations of iMedNet , ... how iMedNet has been able to deliver time ...
(Date:11/4/2015)... 2015 --> ... by Transparency Market Research "Home Security Solutions Market - Global ... - 2022", the global home security solutions market is expected to ... The market is estimated to expand at a CAGR ... 2022. Rising security needs among customers at homes, the ...
Breaking Biology News(10 mins):