NATICK, Mass., Nov. 10 Boston ScientificCorporation (NYSE: BSX) today announced that it has received approval from theU.S. Food and Drug Administration to market its Apex(TM) PTCA(1) DilatationCatheter. The Apex Catheter is a high-performance pre-dilatation ballooncatheter developed specifically to address physicians' needs in treating themost challenging atherosclerotic lesions. It is available for distribution inboth Monorail(R) and Over-The-Wire (OTW) catheter platforms.
The Apex Catheter represents the next generation of dilatation cathetertechnology, utilizing a new Bi-Segment(TM) inner shaft for improvedpushability and flexibility. Additionally, it has a redesigned tip with thesame low profile as the Maverick(R) PTCA Dilatation Catheter for excellentturning and wire tracking.
It is available in a wide array of balloon diameters from 1.5mm up to5.0mm, with balloon lengths ranging from 8mm up to 40mm (for selectdiameters). Both the Apex Monorail and OTW catheters are available in twodifferent 1.5mm designs -- "Apex Push Catheter" and "Apex Flex Catheter." TheApex Push Catheter is designed to enhance pushability for tight lesions, whilethe Apex Flex Catheter is designed to enhance trackability for tortuousarteries. The two 1.5mm Apex Catheter designs enable physicians to select theappropriate catheter based on the clinical situation.
"A much greater number of 'complex' lesions could be more readily crossedand dilated if more advanced, next-generation, catheter technology wereavailable," said James Hermiller, M.D., Director of the InterventionalFellowship at St. Vincent Heart Center of Indiana in Indianapolis. "I believethe Apex Catheter represents a next generation of catheter technology."
"The Apex Catheter is a reflection of Boston Scientific's commitment toproviding physicians with the most complete set of high-performancecardiovascular devices possible," said Hank Kucheman, Senior Vice Presidentand Group President, Cardiovascular. "As an established market leader, welistened to physicians' requests for improvements to existing ballooncatheters, and responded with the advanced technology found in the ApexCatheter."
The Apex Catheter builds on Boston Scientific's reputation for developingmarket-leading balloon catheters. Boston Scientific makes the number oneselling pre- and post-dilatation catheters (Maverick(R) and Quantum(TM)Maverick(R)) in the U.S. market today.
The Apex Catheter is the latest technological development by BostonScientific intended to improve the management of patients with coronaryatherosclerosis undergoing percutaneous coronary intervention (PCI). BostonScientific furthers PCI optimization through a broad range of devices,including ultrasound imaging to assess lesions and balloon catheters anddrug-eluting stents to reopen blocked arteries. This broad portfolio ofdevices supports physicians' efforts to achieve safe and effective outcomesfor their patients.
PTCA dilatation catheters are used in coronary angioplasty and stentingprocedures to open arteries blocked by atherosclerosis, which if leftuntreated can cause heart attack and stroke. Coronary artery diseaserepresents the leading cause of death in the United States, accounting formore than 870,000 deaths each year.(2)
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:http://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) Per Percutaneous Transluminal Coronary Angioplasty
(2) Source:http://www.americanheart.org/downloadable/heart/1166712318459HS_StatsInsideText.pdf (Due to length of URL, please copy and paste into browser).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