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


Next-generation balloon catheter offers enhanced deliverability and expanded options for treating coronary artery lesions

NATICK, Mass. - Boston Scientific Corporation (NYSE: BSX) announces CE Mark and European market launch of the Emerge(TM) 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.

[1] Percutaneous Transluminal Coronary Angioplasty

[2] Source: American Heart Association

CONTACT:

Steven Campanini

508-652-5740 (office)

Media Relations

Boston Scientific Corporation

steven.campanini@bsci.com

SOURCE

Boston Scientific Corporation

Web Site: www.bostonscientific.com

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