Boston Scientific Corporation Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter

NATICK, Mass., April 24, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces CE Mark and European market launch of the Emerge PTCA[1] Dilatation Catheter. The Emerge Catheter is a next-generation pre-dilatation balloon catheter designed specifically to offer exceptional deliverability to address challenging lesions. The company plans to launch the product immediately in CE Mark countries in both Monorail® and Over-The-Wire (OTW) options. Commercial availability is expected in the U.S. and additional international markets later this year.

The Emerge PTCA Dilatation Catheter includes a 1.2 mm diameter balloon option that features an ultra-low 0.017" tip profile and low crossing profiles designed to cross tight lesions. The Emerge 1.2 mm balloon also employs a durable balloon material that provides high rated burst pressure (18 ATM) for sizing flexibility. The Emerge Catheter platform offers a reduced, low-friction shaft profile which allows for simultaneous use of two Monorail balloon catheters in a 6F guide catheter and two OTW balloon catheters in an 8F guide catheter.

“The Emerge Catheter combines several innovative balloon technologies in a single versatile platform,” said Jean Fajadet, M.D., Clinique Pasteur, Toulouse, France, who performed the first procedure in Europe with the Emerge PTCA Dilatation Catheter. “The result is a functional catheter with a low profile and excellent deliverability to facilitate the navigation and crossing of challenging coronary lesions.”

The Emerge Catheter is available in a wide array of balloon diameters from 1.2 mm up to 4.0 mm, with balloon lengths ranging from 8 mm up to 30 mm. Both the Monorail and OTW catheters are available with two distinct shaft technologies designed to provide versatility in addressing different clinical situations. The “Push Technology” (1.2 mm and 1.5 mm) offers a single-segment inner shaft for enhanced pushability. The “Workhorse Technology” (1.2 mm to 4.0 mm) features a Bi-Segment inner shaft designed for excellent deliverability without sacrificing push.

“The Emerge Catheter builds on Boston Scientific’s expertise in developing leading catheter technology and our commitment to offering the most advanced devices to treat coronary artery disease,” said Kevin Ballinger, president of Boston Scientific’s cardiovascular division. “The innovative features and broad range of available options for the Emerge platform enables physicians to select the appropriate catheter based on clinical need, helping to improve outcomes for patients undergoing coronary interventions.”

Coronary artery disease represents the leading cause of death in the United States and Europe, accounting for more than 870,000 U.S. deaths each year and 1.95 million deaths annually in Europe[2]. PTCA dilatation catheters are used in coronary angioplasty and stenting procedures to open arteries blocked by atherosclerosis, which if left untreated can cause heart attack and stroke.

The Emerge 1.2 mm and 1.5 mm PTCA Dilatation Catheters are currently under review by the U.S. Food and Drug Administration, and are not available for sale in the United States.

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that 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 27A of the Securities Act of 1933 and 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 our business plans, new product launches and launch cadence, regulatory approvals, product performance and competitive offerings. 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] Percutaneous Transluminal Coronary Angioplasty

[2] Source: American Heart Association

SOURCE Boston Scientific Corporation