NATICK, Mass., Dec. 15 Boston ScientificCorporation (NYSE: BSX) today announced that the U.S. Food and DrugAdministration (FDA) has approved the Express(R) SD Renal Monorail(R)Premounted Stent System for use as an adjunct to PTRA (percutaneoustransluminal renal angioplasty) in certain lesions of the renal arteries. TheExpress SD System is the first low-profile, pre-mounted stent approved for usein renal arteries in the United States. It is the only FDA-approved renalstent designed to provide additional proximal end support.
"The approval of the Express SD Stent for renal indications providesphysicians with an on-label stenting option for use with PTRA in certainpatients with renal artery disease," said Krishna Rocha-Singh, M.D., F.A.C.C.,of Prairie Cardiovascular Heart Institute in Springfield, Illinois.
"FDA approval for the Express SD Renal Stent is an important step inproviding physicians evidence-based technology to facilitate the management ofrenal artery disease," said Jim Tobin, President and Chief Executive Officerof Boston Scientific. "With the addition of the Express SD Renal Stent,Boston Scientific can now offer customers the industry's leading portfolio ofproducts for endovascular treatment of this disease."
Renal artery disease is the narrowing of the main blood supply to thekidneys due to atherosclerosis, or the formation of plaque within thearteries, which can lead to high blood pressure or poor kidney function. Thedisease can be treated surgically, with medication, or less invasively withangioplasty. Re-narrowing of the arteries can occur after angioplasty, andthe use of stenting as an adjunctive treatment option is intended to assist intheir re-opening.
Two-year results from the RENAISSANCE clinical trial, which was designedto evaluate the safety and efficacy of the Express SD Renal Stent inhypertensive patients with atherosclerotic renal artery stenosis (RAS),demonstrated a statistically significant improvement in systolic bloodpressure and no statistical difference in either diastolic blood pressure orserum creatinine levels from baseline through three years(1). Nine-monthresults demonstrated a binary restenosis rate of 21.3 percent (23/108), lowtarget lesion revascularization (TLR) rates of 8.1 percent (9/111) and nostent thrombosis (0/100)(2).
The Express SD Renal Stent is designed specifically for treatment of therenal arteries by incorporating additional connections in the proximal end ofthe stent, which are intended to provide excellent support, especially inlesions occurring at the opening of the renal artery (ostial lesions). Basedon Maverick(R) Monorail(R) Balloon Catheter technology and TandemArchitecture(TM) Stent Design, the Express SD Renal Stent is designed toprovide strength, precision and deliverability.
Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaningof Section 21E of the Securities Exchange Act of 1934. Forward-lookingstatements may be identified by words like "anticipate," "expect," "project,""believe," "plan," "estimate," "intend" and similar words. Theseforward-looking statements are based on our beliefs, assumptions and estimatesusing information available to us at the time and are not intended to beguarantees of future events or performance. These forward-looking statementsinclude, among other things, statements regarding clinical trials, productperformance, competitive offerings, procedural volume, overall market size andour market position. If our underlying assumptions turn out to be incorrect,or if certain risks or uncertainties materialize, actual results could varymaterially from the expectations and projections expressed or implied by ourforward-looking statements. These factors, in some cases, have affected andin the future (together with other factors) could affect our ability toimplement our business strategy and may cause actual results to differmaterially from those contemplated by the statements expressed in this pressrelease. As a result, readers are cautioned not to place undue reliance onany of our forward-looking statements.
Factors that may cause such differences include, among other things:future economic, competitive, reimbursement and regulatory conditions; newproduct introductions; demographic trends; intellectual property; litigation;financial market conditions; and, future business decisions made by us and ourcompetitors. All of these factors are difficult or impossible to predictaccurately and many of them are beyond our control. For a further list anddescription of these and other important risks and uncertainties that mayaffect our future operations, see Part I, Item 1A - Risk Factors in our mostrecent Annual Report on Form 10-K filed with the Securities and ExchangeCommission, which we may update in Part II, Item 1A - Risk Factors inQuarterly Reports on Form 10-Q we have filed or will file thereafter. Wedisclaim any intention or obligation to publicly update or revise anyforward-looking statements to reflect any change in our expectations or inevents, conditions, or circumstances on which those expectations may be based,or that may affect the likelihood that actual results will differ from thosecontained in the forward-looking statements. This cautionary statement isapplicable to all forward-looking statements contained in this document.(1) Data on File at Boston Scientific (2) Presented by Dr. Krishna Rocha-Singh at ISET, January 2008 CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
SOURCE Boston Scientific Corporation