Healthcare Industry News: SPIRIT III
News Release - August 14, 2006
Abbott Enrolls First Patient in New Clinical Trial of XIENCE(TM) V Drug Eluting StentSPIRIT IV Study Will Evaluate the XIENCE(TM) V Everolimus Eluting Stent System in Broader Patient Population
ABBOTT PARK, Ill., Aug. 14 (HSMN NewsFeed) -- Abbott (NYSE: ABT ) announced today enrollment of the first patient in its SPIRIT IV clinical trial for the continued evaluation of the safety and efficacy of the XIENCE(TM) V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease in a more complex patient population.
XIENCE V received CE Mark approval earlier this year. The system utilizes the highly deliverable and proven MULTI-LINK VISION® coronary stent platform.
Dr. Ali Rizvi, M.D., director of Interventional Cardiology Research at The Heart Center of Indiana in Indianapolis, enrolled the first patient.
"Preliminary results from clinical studies of the XIENCE V stent have been promising. SPIRIT IV has been designed to enroll a broader patient group, including patients with multi-vessel coronary artery disease requiring multi-vessel stenting," said Dr. Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, who is principal investigator for SPIRIT IV. "I look forward to the results of this study of patients that will approximate a real-world population."
The SPIRIT IV study, which will enroll approximately 1,125 patients at approximately 40 sites in the United States, is a single-blinded, multi-center clinical trial. The study allows for the treatment of up to three de novo (previously untreated) native coronary artery lesions, with a maximum of two lesions per vessel, and in some cases, lesions that are located at areas of bifurcation, where one vessel branches off to another. The XIENCE V stent system will be randomized 2:1 to Boston Scientific's TAXUS® EXPRESS2(TM) Paclitaxel-Eluting Coronary Stent System. The primary endpoint of the trial is ischemia-driven target vessel failure (TVF) at 270 days. Patients will be followed out to five years.
"SPIRIT IV will allow us to increase our understanding about the potential of XIENCE V as a next-generation drug eluting stent for physicians caring for the patients with challenging coronary artery disease," said John M. Capek, Ph.D., president, Cardiac Therapies, Abbott Vascular. "We look forward to introducing this therapy in Europe later this year."
Six-month data on the XIENCE V stent system from the SPIRIT II trial will be presented at the European Society of Cardiology meeting in Barcelona, Spain, on September 5.
Abbott's SPIRIT III pivotal study has completed enrollment of 1,002 patients in the randomized U.S. portion of the trial. Enrollment in the 4.0 mm and the Japan arms of the non-randomized portion of its SPIRIT III clinical trial was temporarily suspended earlier this year, but is expected to resume in the near future.
In April 2006, Abbott acquired the vascular intervention and endovascular solutions businesses of Guidant Corporation. Guidant has been the predominant U.S. market leader in metallic stents since the introduction of the company's first stent system in 1997.
About the SPIRIT Family of Trials
The SPIRIT FIRST study of the XIENCE V System, showed positive results at 30 and 180 days for patients with de novo native coronary artery lesions. SPIRIT II and SPIRIT III are large-scale pivotal clinical trials comparing XIENCE V to the TAXUS® Express 2(TM) Paclitaxel Eluting Coronary Stent System.
About Abbott Vascular's Drug Eluting Stent Program
Abbott Vascular's drug eluting stent program is comprised of two flagship investigational products: the XIENCE V Everolimus Eluting Coronary Stent System and the ZoMaxx(TM) Drug-Eluting Coronary Stent System. Both systems include advanced stent platforms and controlled release of a drug from the -olimus class. XIENCE V utilizes the drug everolimus and the highly deliverable and proven MULTI-LINK VISION® coronary stent platform. Everolimus has been shown to reduce tissue proliferation in the coronary vessels following stent implantation. The ZoMaxx drug-eluting stent system features zotarolimus, a compound developed specifically for use on drug-eluting stents, and Abbott's TriMaxx(TM) stainless steel and tantalum stent platform. Abbott Vascular is also developing bioabsorbable drug eluting stents as well as drug eluting stents that utilize a combination of drugs.
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 transforming 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 that are recognized internationally for their safety, effectiveness and ease of use in treating patients with vascular disease. For more information, visit http://www.abbottvascular.com .
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 65,000 people and markets its products in more than 130 countries.
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