NATICK, Mass., March 10 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the schedule of the Company's major events and news announcements at the 59th Annual Scientific Session of the American College of Cardiology/i2 Summit, March 13-16 in Atlanta.
"We look forward to announcing 12-month results from the PERSEUS clinical program, which will provide important data on our third-generation drug-eluting stent, the TAXUS® Element™ Paclitaxel-Eluting Stent," said Keith Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific. "The PERSEUS trials are designed to demonstrate that the proven TAXUS drug and polymer combination can be successfully transferred to the innovative Element platform without compromising safety and efficacy. The TAXUS Element Stent's novel architecture and platinum chromium alloy offer physicians significant improvements in flexibility, visibility and deliverability, as well as reduced recoil."
Schedule of Events (All times are ET; all events are held at the Georgia World Congress Center.)
Monday, March 15
- PERSEUS 12-Month Results. Dean Kereiakes, M.D., will present 12-month safety and efficacy data on the TAXUS Element Stent 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 efficacy of the TAXUS Element Stent compared to Boston Scientific's first-generation TAXUS® Express® Paclitaxel-Eluting Stent in 1,262 patients with de novo lesions. The PERSEUS Small Vessel trial compares the performance of the TAXUS Element Stent in 224 patients with small vessels (greater than or equal to 2.25 to less than 2.75 mm in diameter and less than or equal to 20 mm in length) to a matched historical control group of 125 patients treated with the Express® bare-metal stent. The PERSEUS data will be used to support regulatory approvals in Europe, the U.S. and Japan. Results will be presented from 11:06 to 11:16 a.m. during a late-breaking trial session in the Murphy Ballroom. The Company plans to issue a press release at this time.
- PROMUS® and TAXUS Stents: Multi-Vessel Stenting. Dr. Kereiakes will present results from a pooled analysis of the SPIRIT III and SPIRIT IV clinical trials assessing the performance of the XIENCE V® (PROMUS®) Everolimus-Eluting Stent versus the TAXUS Express Stent in patients undergoing multi-vessel stenting. Results will be presented during a poster session from 1:30 to 4:30 p.m. in Hall B5.
- PROMUS Registry Data. Upendra Kaul, M.D., will present one-year results from the SPIRIT V post-approval registry evaluating the XIENCE V (PROMUS) Stent in real-world practice. Results will be presented during a poster session from 3:30 to 4:30 p.m. in Hall B5.
- HORIZONS AMI Diabetic Analysis. Bernhard Witzenbichler, M.D., will present results from an analysis of the HORIZONS AMI trial on the safety and efficacy of the TAXUS Express Stent in diabetic patients with acute myocardial infarction (AMI) undergoing primary angioplasty. HORIZONS AMI is the largest randomized trial to compare the use of drug-eluting stents to bare-metal stents for the treatment of heart attack patients. Results will be presented during an oral poster session from 4:30 to 4:42 p.m. in Room B315.
Tuesday, March 16
- SYNTAX Data: Stent Thrombosis and Graft Occlusion. Ted Feldman, M.D., will present an analysis of two-year data from the SYNTAX trial assessing the incidence of very late stent thrombosis and graft occlusion in high-risk patients. SYNTAX is the first randomized, controlled clinical trial comparing percutaneous coronary intervention (PCI) using the TAXUS Express Stent to coronary artery bypass graft (CABG) surgery in patients with left main and/or three-vessel disease. Results will be presented during an oral poster session from 8:00 to 8:12 a.m. in Room B315.
- PROMUS and TAXUS Stents: Small Vessels. James Hermiller, Jr., M.D., will present results from a pooled analysis of the SPIRIT III and SPIRIT IV clinical trials assessing the performance of the XIENCE V (PROMUS) Stent versus the TAXUS Express Stent in patients with small vessels. Results will be presented during an oral poster session from 8:24 to 8:36 a.m. in Room B315.
- SYNTAX Data: Renal Insufficiency. David Holmes, M.D., will present an analysis of two-year data from the SYNTAX trial assessing the effect of baseline renal insufficiency on outcomes in patients with left main and/or three-vessel disease who were revascularized with either PCI using a TAXUS Express Stent or CABG. Results will be presented during an oral poster session from 11:18 to 11:30 a.m. in Room B315.
Boston Scientific will present its latest products at booth #414 in the Exhibit Hall, including its drug-eluting stent, cardiac rhythm management, peripheral intervention and imaging technologies.
TAXUS, Express, Element and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE V is a trademark of the Abbott Laboratories group of companies. The PROMUS Stent is a private-labeled XIENCE V Stent manufactured by Abbott and distributed by Boston Scientific. The SPIRIT clinical program is sponsored by Abbott.
The safety and efficacy of the TAXUS Express Stent have not been established in patients with left main and/or multi-vessel disease. In the United States, the TAXUS Element Stent and PROMUS Element Stent are investigational devices and are limited by applicable law to investigational use only and are not available for sale.
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 21E of the Securities Exchange Act of 19 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.
Boston Scientific Corporation
Boston Scientific Corporation
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