MASCOT, Australia, March 15, 2010 /PRNewswire/ -- Boston Scientific Corporation announces that it received Australian Therapeutic Goods Administration (TGA) approval for its PROMUS(R) Element(TM) and TAXUS(R) Element(TM) Stent Systems, the Company's third-generation drug-eluting stent (DES) technology. The Element Stent Systems incorporate a novel platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. The Company is now marketing the PROMUS Element and TAXUS Element Stent Systems in Australia.

The platinum chromium alloy used in the Element Stent Series is a generation beyond cobalt chromium, and is engineered specifically for coronary stenting. This proprietary alloy, when combined with the innovative Element Stent design, offers greater radial strength and flexibility than older alloys such as cobalt chromium, used in the Xience V(TM) and Xience Prime(TM) Stents. Platinum chromium (PtCr) also provides superior visibility and minimized recoil compared to studied cobalt chromium stents.

The platinum chromium alloy and new stent design used in the Element Stent System represent significant innovations in drug-eluting stent technology, said Professor Ian Meredith of Monash Medical Centre, Melbourne. In my experience, the Element platform offers a stenting option that provides enhanced deliverability and visibility with excellent conformability and low recoil. I believe it may offer performance improvements that could simplify procedures and allow treatment of a broader range of patients.

We are proud to introduce our third-generation drug-eluting stent to physicians and patients in Australia, said Mark Wallwork, Managing Director, Boston Scientific Australia. The Element Stent Series is the latest example of Boston Scientific's commitment to DES market leadership and continued innovation. It gives physicians the choice of two proven drug and polymer combinations - used in millions of patients worldwide - on an entirely new stent platform. We are confident our Element Stent Series will further extend our global DES leadership.

The first implant of the PROMUS Element Stent was performed by Professor Ian Meredith.

Supporting Clinical studies

The PROMUS Element Everolimus-Eluting Coronary Stent System is used in the PLATINUM clinical trial, which completed enrollment of 1,531 patients in September 2009 at 133 sites worldwide including five in Australia. PLATINUM is a randomized, controlled, pivotal trial designed to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the PROMUS Element Stent System.

The TAXUS Element Paclitaxel-Eluting Coronary Stent is used in the PERSEUS Clinical Program. The PERSEUS program includes more than 90 clinical sites, including three in Australia, four in New Zealand and one in Singapore. The trial design includes both a randomized, single-blind, non-inferiority workhorse arm (2.75 to 4.00 mm diameter stents), and a small vessel (2.25 and 2.50 mm diameter) superiority trial.

The PROMUS Element Stent System received CE Mark approval in October 2009. The Company anticipates FDA approval for the PROMUS Element system in 2012. The TAXUS Element Stent System was launched in select international markets in May 2009. CE Mark approval for the TAXUS Element system is expected in the second quarter of 2010, and FDA approval is expected in 2011.

In the U.S., the PROMUS Element and TAXUS Element Stent Systems are investigational devices and are limited by applicable law to investigational use only and are not available for sale. In the EEA, the TAXUS Element Stent System is CE mark pending and 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: http://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 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, regulatory approvals, competitive offerings, product performance and our market position. 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.

1. To date. Test conducted at Boston Scientific. Data on file.

2. Data on file. Compared to XIENCE V(TM) and Endeavor(TM) stents. Bench tested. Tests performed on TAXUS(TM) Element(TM) stent. Indicative of performance of PROMUS(TM) Element(TM). XIENCE is a trademark of Abbott Laboratories group, Endeavor is a trademark of Medtronic Corporation.

SOURCE: Boston Scientific Corporation

CONTACT: Contact: Geraldine Varoqui, Director International PublicRelation, Tel: +49-2102-489-461, Mob: +49-170-782-85-58, varoquig@bsci.com