NATICK, Mass., Feb. 17, 2011 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced its launch of the PROMUS® Element™ Everolimus-Eluting Coronary Stent System and TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in India. Both Element Systems incorporate the same novel platinum chromium (PtCr) alloy, innovative stent design and advanced catheter delivery system, and represent the Company’s third-generation drug-eluting stent (DES) technology.
India is one of the fastest-growing DES markets in the world, with the number of coronary drug-eluting stents implanted annually estimated at more than 150,000. In 2010, the Company received approval from the Drugs Controller General of India to market the Element Systems.
“The new platinum chromium alloy and stent design of the PtCr Element Stent series represent significant innovations in DES technology,” said Ashok Seth, M.D., Fortis Escort Heart Institute, New Delhi. “I believe the Element platform offers performance improvements that could simplify procedures and allow treatment of a broader range of patients.”
The PtCr Element Stent series features a novel platinum chromium alloy and innovative stent design, which combine to offer greater radial strength, flexibility and visibility 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 platinum chromium alloy provides exceptional visibility while enabling the use of thinner struts compared to prior-generation stents(1) without compromising strength.
“The PROMUS and TAXUS Element Stent Systems give physicians in India a choice of two proven drug and polymer combinations – used in millions of patients worldwide – on an entirely new platform,” said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. “The PtCr Element System highlights our commitment to DES market leadership and continued innovation for physicians and their patients.”
“A key component of our growth strategy involves expanding our footprint in emerging markets like India, where we are making significant investments in sales, distribution and clinical infrastructure,” said Ray Elliott, President and Chief Executive Officer of Boston Scientific. “Our PtCr stent technology platform provides a significant advantage in this fast-growing market.”
The PROMUS Element Stent is being evaluated in the PLATINUM clinical trial, which completed enrollment of 1,532 patients in September 2009 at more than 140 sites worldwide. PLATINUM is a randomized, controlled, pivotal trial designed to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the PROMUS Element Stent System. In September 2010, data were presented on 30-day and nine-month clinical outcomes and nine-month quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) supporting the safety and efficacy of the PROMUS Element Stent.
The TAXUS Element Stent is being evaluated in the PERSEUS trial, which reported 12-month results in March 2009, demonstrating positive safety and efficacy outcomes in workhorse lesions for the TAXUS Element Stent System compared to the TAXUS® Express2® Stent System. The PERSEUS clinical program compared the TAXUS Element Stent to prior-generation Boston Scientific stents in more than 1,600 patients in two parallel trials at 90 centers worldwide.
The Company received CE Mark for the PROMUS Element Everolimus-Eluting Stent System in October 2009 and for the TAXUS Element Paclitaxel-Eluting Stent System in May 2010. The TAXUS Element Stent will be commercialized in the U.S. as the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System; the PROMUS Element Stent will be commercialized as the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System.
In the U.S., the ION Stent System and PROMUS Element Plus Stent System are investigational devices, limited by applicable law to investigational use only and not available for sale.
About 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: www.bostonscientific.com.
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This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding new product launches and launch cadence, potential growth of medical device markets in India, regulatory approvals, clinical trials, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
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(1) Based on bench testing. Data on file with Boston Scientific.