Healthcare Industry News: SYNERGY Stent
News Release - November 1, 2011
Boston Scientific Announces Schedule of Events at TCT Scientific SymposiumClinical presentations to include 12-month data on fourth-generation SYNERGY™ Stent
NATICK, Mass., Nov. 1, 2011 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE:BSX ) releases the schedule of its major events and product-related clinical research for the Cardiovascular Research Foundation's (CRF) 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, scheduled for November 7 - 11 in San Francisco. TCT is designed to provide new insights for physicians who treat patients with cardiovascular disease and other vascular health issues.
"Among the anticipated clinical results, we particularly look forward to presenting primary endpoint data from the EVOLVE trial, which is evaluating the performance of the SYNERGY™ Stent, our fourth-generation drug-eluting coronary stent platform," said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific's Cardiology, Rhythm and Vascular Group. "The SYNERGY Stent is designed to combine the acute performance advantages of the platinum chromium PROMUS Element™ Stent with an innovative bioabsorbable drug-polymer combination engineered to create an ultra-thin, uniform coating that is designed to reabsorb within four months, leaving only a bare-metal stent in the treated vessel."
Schedule of Events (All times are Pacific time, with events to be held at the Moscone Center unless otherwise indicated.)
Tuesday, November 8
* PERSEUS Workhorse and Small Vessel Two-Year Results. Louis Cannon, M.D., will present two-year safety and efficacy data on the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System (TAXUS® Element™) from the PERSEUS clinical program, which is studying more than 1,600 patients in two parallel trials at 90 centers worldwide. The pivotal PERSEUS Workhorse trial is evaluating the safety and effectiveness of the ION Stent compared to Boston Scientific's first-generation TAXUS® Express® Paclitaxel-Eluting Coronary Stent System in more than 1,200 patients with de novo lesions. The PERSEUS Small Vessel trial compares the performance of the ION Stent in 223 patients with small vessels to a matched historical control group of 125 patients treated with the Express® bare-metal stent. Results will be presented from 8 to 10 a.m. during a poster session in Hall D. The Company plans to issue a press release announcing trial results during this time.
* Comparison of PERSEUS/ATLAS Two-Year Trial Data. Dean Kereiakes, M.D., will present an analysis of case-matched data from 2,298 patients enrolled in the PERSEUS and TAXUS ATLAS clinical trials. The study will compare two-year clinical outcomes of the ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System (TAXUS Element) to the TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System. Both stents use the same drug and polymer but differ in metal alloy composition, stent design and strut thickness. Results will be presented from 8 to 10 a.m. during a poster session in Hall D. The Company plans to issue a press release announcing trial results during this time.
* PLATINUM Long Lesion Primary Endpoint Data. Paul S. Teirstein, M.D., will present 12-month primary endpoint data from the PLATINUM Long Lesion trial, which compares outcomes with the PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent System to a pre-defined performance goal based on historical results with the 32-mm TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System in patients with long lesions. Results will be presented from 8 to 10 a.m. during a poster session in Hall D. The Company plans to issue a press release announcing trial results during this time.
* TAXUS Liberte Post-Approval Study. David Lee, M.D., will present baseline data and in-hospital outcomes for the first 3,600 patients from the TAXUS Liberte post-approval study, designed to evaluate "real-world" clinical outcomes data for the TAXUS Liberte Paclitaxel-Eluting Coronary Stent System in combination with prasugrel therapy. Results will be presented from 8 to 10 a.m. during a poster session in Hall D.
* SYNTAX Trial at Four Years. David Holmes, M.D., will present four-year follow-up data in the overall patient group from the landmark SYNTAX trial, the first randomized, controlled clinical trial comparing percutaneous coronary intervention using drug-eluting stents to coronary artery bypass graft surgery in patients with left main and/or three-vessel disease. Results will be presented from 8 to 10 a.m. during a poster session in Hall D.
* SYNTAX Three-Vessel Subgroup at Four Years. Friedrich Mohr, M.D., Ph.D., will present four-year follow-up data in the three-vessel subgroup from the SYNTAX trial. This analysis will be presented during an oral abstract session at 11:33 a.m. in Room 125.
* SYNTAX Left Main Subgroup at Four Years. Prof. Patrick W. Serruys, M.D., Ph.D., will present a detailed examination of four-year follow-up clinical results in patients with left main disease from the SYNTAX trial. This analysis will be presented during an oral abstract session at 11:46 a.m. in Room 121.
* CABANA Post-Approval Study. L. Nelson Hopkins, M.D., will present results from an analysis of the CABANA post-approval study, designed to compile early clinical outcomes data in high surgical risk patients with carotid artery stenosis treated with the Company's Carotid WALLSTENT® Monorail® Endoprosthesis used in conjunction with its FilterWire EZ™ Embolic Protection System. Results will be presented during an oral poster session at 11:46 a.m. in Room 112. The Company plans to issue a press release announcing trial results at the conclusion of the presentation.
* ASAP Registry Results for WATCHMAN® Device. Horst Sievert, M.D., will present clinical data from the ASA Plavix (ASAP) Registry, which is designed to assess left atrial appendage (LAA) closure using the WATCHMAN® Device in patients with contraindications to warfarin. The device was developed by Atritech, acquired by Boston Scientific in 2011. Results will be presented during an oral abstract session at 2:20 p.m. in Room 130.
Wednesday, November 9
* Breakfast Symposium on Chronic Total Occlusions. The Company will sponsor a breakfast symposium titled "Treating Chronic Total Occlusions: Advanced Technology and Techniques," chaired by Tony Das, M.D., and Dierk Scheinert, M.D., from 6:30 to 8 a.m. in Room 132. Presentations will review tools and techniques for crossing difficult lesions in the peripheral vasculature and introduce the TruePath™ CTO Device.
* Boston Scientific-Sponsored Evening Symposium. The Company will sponsor an evening symposium titled "Navigating the Evolving Opportunities for the Interventional Cardiologist," chaired by Ted Feldman, M.D. The event will feature presentations by leading interventional cardiologists examining the future landscape of interventional medicine and a keynote address by US Airways Captain Chesley "Sully" B. Sullenberger, III, titled "Leading Through Change." It will take place at the Hilton San Francisco Union Square, Grand Ballroom A/B, from 8 to 9:30 p.m. with a dinner reception beginning at 7 p.m.
Thursday, November 10
* Breakfast Symposium on Coronary Stenting. The Company will sponsor a breakfast symposium titled "Lessons from New Data in Coronary Stenting," chaired by Louis Cannon, M.D., and Ian Meredith, M.B.B.S., Ph.D., from 6:30 to 8 a.m. in Room 124. Presentations will examine clinical data from challenging PCI subsets and preview new research on bioabsorbable drug delivery from the EVOLVE trial.
* REPRISE Clinical Program for Lotus™ Valve System. Ian Meredith, M.B.B.S., Ph.D., will present an update on the REPRISE clinical program, which is evaluating the Lotus™ Valve System, the first fully repositionable device for percutaneous aortic valve replacement to treat patients with severe aortic stenosis. The Lotus Valve was developed by Sadra Medical, acquired by Boston Scientific in 2011. The spotlight session begins at 8:58 a.m. in Room 135.
Friday, November 11
* Late-Breaking Trial: EVOLVE Endpoint Data. Principal Investigator Ian Meredith, M.B.B.S., Ph.D., will present primary endpoint data from the EVOLVE trial during a late-breaking clinical session at 11 a.m. in the Main Arena. EVOLVE is a prospective, randomized, non-inferiority trial that compares two dose formulations of everolimus on Boston Scientific's SYNERGY Coronary Stent to the PROMUS Element Everolimus-Eluting Coronary Stent in patients with de novo coronary artery lesions. The SYNERGY Stent features the Company's proprietary platinum chromium alloy and uses a bioabsorbable polymer and everolimus drug combination to create an ultra-thin, uniform coating confined to the outer surface of the stent. The Company plans to issue a press release announcing trial results at the conclusion of the presentation.
* Late-Breaking Trial: COBRA Endpoint Data. Subhash Banerjee, M.D., will present 12-month endpoint data from the COBRA trial during a late-breaking clinical session at 12:40 p.m. in the Main Arena. COBRA is a prospective, randomized, multi-center trial that compares CryoPlasty® Therapy using the PolarCath™ Peripheral Dilatation System to conventional balloon angioplasty for the post-dilatation of nitinol stents in the superficial femoral artery of diabetic patients. The Company, which provided grant support for the COBRA trial, plans to issue a press release announcing trial results at the conclusion of the presentation.
Boston Scientific will present its latest drug-eluting stent, peripheral intervention and imaging technologies at booth #1617 in the Exhibit Hall November 8-10 from noon to 5 p.m.
In the U.S., the SYNERGY Stent, PROMUS Element Stent, WATCHMAN Device, Lotus Valve System and TruePath CTO Device are investigational devices and are limited by applicable law to investigational use only and are not available for sale. The safety and efficacy of the Company's drug-eluting stents have not been established in patients with left main or three-vessel disease.
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.
Cautionary Statement Regarding Forward-Looking Statements
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 clinical trials, scientific activities, product performance, competitive offerings and growth strategies. 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.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
Source: Boston Scientific
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