-- XIENCE V Data From the SPIRIT IV Trial to be Presented as a Late Breaking Trial on Sept. 23
ABBOTT PARK, Ill., Sept. 16 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today announced the company's schedule of key data presentations at the Cardiovascular Research Foundation's 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C., to be held Sept. 21 – 25. Highlights include late-breaking two-year data from SPIRIT IV, one of the largest randomized, head-to-head clinical trials between two drug eluting stents – Abbott's XIENCE V® Everolimus Eluting Coronary Stent System and Boston Scientific's TAXUS® Express Paclitaxel-Eluting Coronary Stent System. In addition, the company will present data on two key pipeline products: the first-of-its-kind MitraClip® system, an investigational device in the United States; and the bioresorbable vascular scaffold (BVS), currently under clinical investigation outside the United States.
"We continue to strengthen our leadership position in the treatment of vascular disease with significant new data that support our market-leading XIENCE V stent, which has become the gold standard of drug eluting stents around the world," said Robert Hance, senior vice president, vascular, Abbott. "We also continue to make progress with our industry leading vascular pipeline, and we look forward to presenting additional data on our key pipeline products, including the MitraClip system and our bioresorbable vascular scaffold."
Key presentations are as follows (all times are Eastern):
SPIRIT IV: Two-year results from SPIRIT IV will be presented by Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center, during the first late-breaking clinical trials session at 11 a.m. in the Main Arena on Thursday, Sept. 23. SPIRIT IV is one of the largest randomized clinical trials ever conducted that compares two drug eluting stents.
The study enrolled 3,690 patients – including more than 1,000 patients with diabetes. Dr. Stone is the principal investigator of the SPIRIT IV trial.
SPIRIT III: Four-year results from SPIRIT III will be presented during the Scientific Symposia starting at 1 p.m. on Wednesday, Sept. 22. SPIRIT III is a prospective, multi-center, randomized, single-blind, controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients (669 XIENCE V patients and 333 TAXUS patients) with either one or two de novo coronary artery lesions.
XIENCE V USA: One-year results from XIENCE V USA, including subset data, will be presented during the Scientific Symposia starting at 3:30 p.m. on Wednesday, Sept. 22. XIENCE V USA is a post-market, real-world, single-arm registry evaluating outcomes in more than 5,000 XIENCE V patients based in the U.S., with follow-up out to five years. Subset data presented at TCT will include information on patient quality of life after receiving a XIENCE V stent and data on the safety and efficacy of XIENCE V in real-world patients with acute myocardial infarction.
EVEREST II: During the Scientific Symposia starting at 3:30 p.m. on Wednesday, Sept. 22, a number of presentations will review new data from EVEREST II, the landmark trial of the MitraClip system, a first-of-its-kind, catheter-based device for mitral valve repair. In addition, the MitraClip system will be highlighted during the "Hottest Topic of 2010: Transcatheter Valve Therapy" session starting at 9:30 a.m. on Thursday, Sept. 23, and the "Best of the Best TCT 2010 Abstracts" starting at 3:16 p.m. on Friday, Sept. 24. The MitraClip system received CE Mark in March 2008. In the U.S., the MitraClip system is limited by federal law to investigational use only and is not available for sale. The MitraClip system is currently under review for approval by the U.S. Food and Drug Administration.
ABSORB: Nine-month data on 45 patients and six-month data on all 101 patients from the second phase of ABSORB will be presented on Wednesday, Sept. 22. The ABSORB trial is evaluating Abbott's bioresorbable vascular scaffold (BVS), which aims to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the BVS is designed to be slowly metabolized and eventually resorbed by the body. Abbott's BVS device is under clinical investigation outside the U.S. The device is currently in development at Abbott Vascular and not available for sale.
As part of its commitment to ongoing medical education, Abbott is providing support for a number of symposia on key topics for interventional cardiologists throughout the conference. In addition, the Abbott booth (#1456) will feature the company's vascular pipeline, as well as resources and programs for physicians and patients.
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 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 V, including important safety information, is available online at www.xiencev.com or www.abbottvascular.com/en_US/content/document/eIFU_XienceV.pdf.
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 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.