Data presented on Xience V, Abbott's vascular pipeline
September 17, 2010 - The Cardiovascular Research Foundation's 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) symposium, to be held Sept. 21- 25, will feature presentations on Xience V data.
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, Abbott will present data on two key pipeline products: the MitraClip system, an investigational device in the United States; and the bioresorbable vascular scaffold (BVS), currently under clinical investigation outside the United States.
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 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.
Abbott's Xience V drug-eluting stent is marketed in the U.S., Europe, Japan and other international markets.
For more information: www.xiencev.com
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