Guidant Announces Excellent Preliminary Results of Paclitaxel Eluting Stent Trial; DELIVER and ELUTES Data Continue to Support Benefit of Paclitaxel Eluting Stents.Business Editors/Health & Medical Writers INDIANAPOLIS, Ind. & PARIS--(BW HealthWire)--May 23, 2002 Guidant Corporation (NYSE NYSE See: New York Stock Exchange :GDT GDT Global Descriptor Table GDT Geographic Data Technology Inc. GDT Gas Discharge Tube (energy, electrotechinical and electronics) GDT Getting Things Done GDT Geometric Dimensioning & Tolerancing GDT Ground Data Terminal )(PCX (1) A bitmapped graphics file format that handles monochrome, 2-bit, 4-bit, 8-bit and 24-bit color and uses RLE to achieve compression ratios of approximately 1.1:1 to 1.5:1. Images with large blocks of solid colors compress best under the RLE method. See PC Paintbrush. :GDT), a world leader in the treatment of cardiac and vascular disease, today announced preliminary results from the DELIVER Clinical Trial, a single-blinded, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. study comparing the paclitaxel-coated ACHIEVE(TM) Drug Eluting Coronary Stent coronary stent Intracoronary stent Cardiology An expandable tubular device which can be inserted percutaneously, and left within a coronary artery lumen to maintain its patency Pros Clinical and angiographic outcomes are better with intracoronary artery stent to an uncoated bare-metal control stent. The DELIVER Clinical Trial reported a 30-day major adverse cardiac events (MACE) rate of 0.8 percent, consistent with MACE rates previously observed in Guidant's family of stents. Group A, enrolling 524 patients, reported a 1.2 percent MACE rate at 30 days; Group B, enrolling 519 patients, reported a MACE rate of 0.4 percent. The MACE rates include any deaths, myocardial infarctions and target lesion target lesion Dermatology A lesion typical of erythema multiforme–EM in which a vesicle is surrounded by an often hemorrhagic maculopapule; EM is often self-limited, of acute onset, resolves in 3-6 wks, and has a cyclical pattern; EM lesions are 'multiform' revascularization within the 30-day period. Additionally, Guidant reported a sub-acute thrombosis rate of 0.2 percent in both arms, also within 30 days. Because the study is blinded, it is not known at this time which group received the ACHIEVE Stent System and which group received the control stent. "The excellent 30-day MACE data from the DELIVER study are encouraging, and we look forward to reporting eight-month angiographic and nine-month clinical follow-up," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "As we've seen from the data recently reported at EuroPCR, stent and delivery system technology will be important in determining the overall performance of drug eluting stents. As this breakthrough technology evolves, we anticipate that drug eluting stents that leverage state-of-the-art stent design and delivery system technology will provide opportunities for significant improvements in clinical performance." William Knopf, M.D., of St. Joseph's Hospital St. Joseph's Hospital may refer to: In the United States:
"These promising preliminary results add to the growing repository of clinical data demonstrating the potential benefit of paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); eluting stents for treating coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. ," said Dr. Knopf. The 12-month results from Cook's ELUTES Clinical Study reported today continue to support the benefit of paclitaxel in drug eluting stents utilizing Cook's proprietary drug coating technology. The study reported no late thrombosis, death or Q-wave myocardial infarctions. Additionally, 12-month target lesion revascularization was reported as 5 percent in the 2.7 micron g/mm(2) arm of the study, compared to 16 percent in the control arm. The DELIVER Clinical Trial is designed to serve as the basis for Guidant's submission for U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval of the ACHIEVE Stent System on behalf of Cook Incorporated. The new ACHIEVE Drug Eluting Coronary Stent System is manufactured by Cook Incorporated and will be distributed worldwide exclusively by Guidant. Enrollment of 1,043 patients in the study was completed in early March, in less than four months. Guidant will host an investor briefing at EuroPCR tomorrow, Friday, May 24, at 11:00 a.m. Paris time/5:00 a.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT . The briefing will be hosted by Guido Neels, president, Europe, Middle East, Africa and Canada, Guidant, and John Capek. Also in attendance will be a panel of interventional cardiologists including Tony Gershlick, M.D. (Leicester, Britain) and Dr. Knopf. A live webcast of Guidant's conference call will be accessible through Guidant's website at www.guidant.com/webcast or at CCBN's individual investor center at www.companyboardroom.com. The webcast will be archived on both websites for future on-demand replay. Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 10,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions. For more information visit www.guidant.com. |
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