Healthcare Industry News: SYNTAX trial
News Release - May 15, 2007
Boston Scientific Announces Schedule for EuroPcr 2007Company to release broad range of clinical data on leading drug-eluting stent portfolio
NATICK, Mass., May 15 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced the schedule of the Company's major events and press announcements at the annual Paris Course on Revascularization (EuroPCR), which will runs from May 22 to 25 in Barcelona, Spain.
"We will be announcing new data from several of our clinical trials and registries, adding to the knowledge base for treating coronary artery disease," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "Pooled data from our ARRIVE registries will shed light on key predictors for stent thrombosis in real-world DES use. Additional data will provide insight into the performance of our market-leading TAXUS® paclitaxel-eluting stent systems as well as our new everolimus-based PROMUS(TM) (XIENCE(TM) V) stent system, reinforcing Boston Scientific's role as the only company offering two distinct drug-eluting stent platforms."
Schedule of Events (all times are local Barcelona)
Tuesday, May 22
* The Great Debate on DES. The Company will host a symposium entitled "The Great Debate on Coronary Drug-Eluting Stents," chaired by Jean Marco, M.D., and Steven Nissen, M.D., from 1:30 - 3:15 p.m. in Room 1 of The Centre de Convencions Internacional de Barcelona. Experts will debate and answer questions from interventional cardiologists related to coronary drug-eluting stent usage in daily practice.
* TAXUS VI four-year data. At 5:01 p.m., Professor Eberhard Grube, M.D., will present four-year results from the TAXUS VI trial in a late- breaking session. This randomized, double-blind trial is designed to assess the safety and efficacy of a moderate-release (non- commercialized) formulation paclitaxel-eluting stent versus a bare metal stent control group. Data will be presented on examined subgroups including patients with long lesions, overlapping stents, and small vessels. The Company plans to issue a press release at this time.
* Predictors of Stent Thrombosis in real-world use. Two-year results from the ARRIVE 1 registry and pooled one-year data from ARRIVE 1 & 2 will be presented by David Dobies, M.D., F.A.C.C., at 5:07 p.m. in a late- breaking session. Data will focus on predictors of stent thrombosis in real-world patients treated with drug-eluting stents. The Company plans to issue a press release at this time.
* SYNTAX trial update. In a late-breaking trial session at 5:46 p.m., Patrick Serruys, M.D., will present final enrollment numbers for SYNTAX, a randomized, controlled clinical trial with nested registries designed to compare 12-month MACCE rates between the company's TAXUS® Express2(TM) paclitaxel-eluting coronary stent system and coronary artery bypass graft (CABG) treatment. The trial will study patients with three vessel disease and/or left main disease, a level of patient and lesion complexity not examined in prior DES studies. SYNTAX recently completed enrollment of more than 3,000 patients at 85 sites in Europe and the United States.
* SPIRIT Trial Results -- XIENCE(TM) V (PROMUS(TM)) Stent and TAXUS Stent. At 6:17 p.m., results from Abbott's SPIRIT I, II and III clinical trials will be presented by Gregg W. Stone, M.D., at a late-breaking trial session. In addition to a three-year update on the SPIRIT FIRST trial results, Dr. Stone will provide a meta-analysis of data from patients in SPIRIT II and SPIRIT III treated with the XIENCE V (PROMUS) Stent or the TAXUS Express2 Stent. The SPIRIT family of trials is designed to evaluate the XIENCE V Everolimus-Eluting Coronary Stent System, manufactured and sold by Abbott, and also marketed by Boston Scientific as the PROMUS Stent, versus the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in the treatment of coronary artery disease. The Company plans to issue a press release at this time.
Wednesday, May 23
* Focus Session on DES in diabetics(1). The Company will sponsor a focus session entitled "Optimizing coronary drug-eluting stent results in diabetics," chaired by Prof. Sigmund Silber, M.D., from 2:00 - 4:30 p.m. in Room 9. In addition to a live case transmission, experts will review practical techniques and strategies for dealing with PCI in diabetic patients.
(1) The safety and effectiveness of the TAXUS Express(TM) Stent have not been established in patients with diabetes.
Thursday, May 24
* Focus Session on carotid artery stenting. The Company will sponsor a focus session entitled "Clinical and technical considerations for daily carotid artery stenting practice," chaired by Nick Hopkins, M.D., from 2:00 - 4:30 p.m. in Room 6. In addition to a live case transmission, experts will review key clinical data and technology selection criteria as well as basic neurorescue techniques.
* Analyst Meeting. From 9:00-10:00 a.m., the Company will host an analyst meeting at the Hotel Hilton Diagonal Mar. The meeting is open to the media. Registration is required for admittance. This meeting is being webcast and can be accessed at Boston Scientific's website, www.bostonscientific.com. Please visit the website for details on how to access the webcast. A replay of the webcast will be archived and available in the Webcast and Archives section of the Investor Relations site at www.bostonscientific.com.
Boston Scientific will present its latest innovations at booth D08 in the Exhibit Hall, including its drug-eluting stent program and peripheral treatment options. Additionally, the Company will introduce a software update for the iLab(TM) Ultrasound Imaging System, which further enhances compatibility and connectivity of iLab's IVUS images with Picture and Communication Systems (PACS) at cardiac catheterization labs.
PROMUS, TAXUS, Express and Express2 are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott. The SPIRIT Clinical Program is sponsored by Abbott. The PROMUS Stent is not approved for sale in the U.S.
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.
This press release contains forward-looking statements. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
Source: Boston Scientific
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