Healthcare Industry News: SPIRIT III
News Release - August 31, 2009
Abbott Launches Next-Generation XIENCE PRIME(TM) Drug Eluting Stent in International MarketsNew Cobalt Chromium Stent Offers Enhanced Deliverability with a Broad Matrix of Sizes - Built Upon the Proven Track Record of Superior Clinical Outcomes of Abbott's Market-Leading XIENCE V(R) Drug Eluting Stent
BARCELONA, Spain, Aug. 31 (Healthcare Sales & Marketing Network) -- Abbott (NYSE: ABT ) today announced at the European Society of Cardiology Congress the widespread availability of its next-generation XIENCE PRIME(TM) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE PRIME, which received CE Mark (Conformite Europeenne) in June, offers a novel stent design and a delivery system designed for greater flexibility and enhanced deliverability. XIENCE PRIME is now widely available in Europe and in select countries throughout Asia-Pacific and Latin America.
"Abbott's XIENCE PRIME is an improvement in design, deliverability and conformability, all of which can be distinctly observed during coronary stent procedures, in both everyday and complex lesions," said Antonio Bartorelli, M.D., director of the Interventional Cardiology Department of the Centro Cardiologico Monzino, University of Milan, Italy. "XIENCE PRIME is designed to be easily deliverable even in complex cases and very long lesions."
XIENCE PRIME utilizes the same well-studied drug and proven biocompatible polymer as Abbott's market-leading XIENCE V® Everolimus Eluting Coronary Stent System. XIENCE PRIME is based upon the well-tested design used in the MULTI-LINK VISION® 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.
"XIENCE PRIME leverages the superior outcomes from the extensive body of clinical evidence from the SPIRIT family of clinical trials, and offers design and delivery system properties that make it even easier for a physician to appropriately reach and treat a lesion," said Patrick Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcenter, Erasmus University Hospital, Rotterdam, the Netherlands. "The XIENCE PRIME stent is designed to improve stent deliverability, minimize vessel injury and provide easy access to lesions in complex anatomy."
XIENCE PRIME uses cobalt chromium technology, and has one of the thinnest drug eluting stent struts available, while maintaining strength to support the vessel. It provides excellent visibility under X-ray during the stent implantation procedure. XIENCE PRIME is available in a broad size matrix, including XIENCE PRIME SV for small vessels and XIENCE PRIME LL for long lesions.
"XIENCE PRIME reflects Abbott's commitment to innovation, and based on the positive physician feedback we've received from our post-market evaluations, XIENCE PRIME is poised to become the market-leading drug eluting stent across Europe," said Robert Hance, senior vice president, vascular, Abbott.
Building Upon the SPIRIT Body of Evidence
In the SPIRIT family of trials, XIENCE V demonstrated superiority to Boston Scientific's TAXUS® Paclitaxel Eluting Coronary Stent System in its primary endpoints in two separate randomized clinical trials. In the SPIRIT II* trial, XIENCE V demonstrated a statistically superior 69 percent reduction of in-stent late loss (a measure of vessel re-narrowing) at six months compared to TAXUS. In the SPIRIT III** trial, XIENCE V demonstrated a statistically superior 50 percent reduction of in-segment late loss at eight months compared to TAXUS.
Long-term results further reinforce the excellent clinical outcomes, with XIENCE V demonstrating an 88 percent reduction in the risk of cardiac death (0.5 percent for XIENCE V vs. 4.2 percent for TAXUS, p-value=0.024) *** and a 57 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (6.4 percent for XIENCE V vs. 14.9 percent for TAXUS, p-value=0.029)*** at three years in the SPIRIT II trial. At two years in the SPIRIT III trial, XIENCE V demonstrated a 45 percent reduction in the risk of MACE compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS, p-value=0.004)***. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, and is defined as a composite of cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (ID-TLR driven by lack of blood supply) for the SPIRIT II and SPIRIT III trials.
Additionally, in the SPIRIT V (five) international, single-arm study of 2,663 patients in Europe and Asia-Pacific, XIENCE V demonstrated a very low 1.8 percent rate of target lesion revascularization (TLR), a 0.7 percent rate of definite/probable stent thrombosis and a 5.1 percent rate of MACE at one year, in a diverse, "real world" population of patients and lesion types. For the SPIRIT V trial, MACE is defined as a composite of cardiac death, heart attack (myocardial infarction not clearly attributed to a non-target vessel), or TLR.
Data from the company's SPIRIT IV trial comparing XIENCE V to TAXUS will be presented at the Transcatheter Cardiovascular Therapeutics annual meeting in September 2009. With 3,690 patients, the SPIRIT IV trial is one of the largest head-to-head randomized clinical trials between two drug eluting stents and includes more than 1,000 patients with diabetes. Across the SPIRIT family of trials, Abbott plans to study approximately 22,000 patients treated with an everolimus eluting stent.
XIENCE PRIME is the latest innovation from Abbott's robust vascular research program, which 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, and a fully bioabsorbable drug eluting coronary device. All products 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.
XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions < / = 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, 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.
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 www.abbott.com.
* In the SPIRIT II trial, both TAXUS Express2 (73 percent of lesions) and TAXUS Liberte (27 percent of lesions) were used as controls.
** In the SPIRIT III trial, TAXUS Express2 was used as the control.
*** Event rates are based on Kaplan-Meier estimates. P-values are for descriptive purposes only.
EDITOR'S NOTE: Additional background information, including fact sheets and images, are available to members of the international media through the XIENCE PRIME media kit at www.xienceprimemediakit.com
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