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Boston Scientific Announces Clinical Data Supporting Safety and Efficacy of Platinum Chromium Promus Element‚Ñ¢ Stent

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Boston Scientific Announces Clinical Data Supporting Safety and Efficacy of Platinum Chromium Promus Element‚Ñ¢ Stent

09/23/2010
Nine-month Results From PLATINUM Clinical Program Presented at TCT NATICK, Massachusetts, September 22, 2010 /PRNewswire/ Boston Scientific Corporation announced data from its PLATINUM QCA study, which is designed to evaluate the Company’s PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent.The results provided 30-day and nine-month clinical outcomes and nine-month quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) data supporting the safety and efficacy of the PROMUS Element Stent. Analysis of the data was presented by Ian Meredith, MBBS, PhD, Director of Cardiology at the Monash Medical Centre in Melbourne, Australia and Principal Investigator of the PLATINUM QCA study, at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, D.C. The PROMUS Element Stent features a novel platinum chromium (PtCr) alloy and innovative stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil. The stent geometry helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density PtCr alloy provides superior visibility while permitting thinner struts compared to prior-generation stents[1]. "The nine-month angiographic and IVUS data from the PLATINUM QCA study are impressive and show the acute performance advantages of the platinum chromium PROMUS Element Stent," said Prof. Meredith. "With the same drug and polymer loading and comparable release kinetics as the PROMUS(R) Stent, the PROMUS Element Stent achieved similar late loss and significantly better stent apposition. These results give me great confidence in the transferability of the everolimus drug and its proven clinical outcomes, as well as the potential benefits of the new platinum chromium alloy." The PLATINUM clinical program is evaluating the safety and efficacy of the PROMUS Element Stent in five multi-center studies totaling more than 1,800 patients, including a randomized controlled trial for workhorse lesions, as well as single-arm studies evaluating small vessels, long lesions and pharmacokinetics. The prospective, single-arm PLATINUM QCA study enrolled 100 patients at 14 sites. The PLATINUM QCA primary endpoint of 30-day composite cardiac events was 1.0 percent, which included cardiac death (0.0 percent), myocardial infarction (0.0 percent), target lesion revascularization (TLR, 1.0 percent) and stent thrombosis (ARC[2] definite/probable, 1.0 percent). Of the 100 patients studied, one patient experienced a peri-procedural stent thrombosis and TLR. No additional major clinical events were reported from 31 days to nine months. The study also met its pre-specified efficacy endpoint of in-stent late loss in workhorse lesions at nine months as measured by QCA compared to historical TAXUS(R) Express(R) Stent data. The PROMUS Element nine-month in-stent late loss of 0.17 mm plus or minus 0.25 mm was superior to the performance goal of 0.44 mm (pAbout Boston Scientific Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com [1] Based on bench testing. Data on file with Boston Scientific. [2] Academic Research Consortium [3] The TAXUS Element Stent System will be commercialized as the ION(TM) Paclitaxel-Eluting Platinum Chromium Coronary Stent System in the U.S. Source: Boston Scientific Corporation ig@bsci.com
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