NATICK, Mass., April 7, 2014 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval in Europe for the Expect™ Slimline (SL) Needle, which is now globally available for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA) procedures. The product's design incorporates extensive customer feedback and is used to collect tissue samples to diagnose and stage malignancies in organs adjacent to the gastrointestinal tract. The Expect Slimline Needle is on contract with four leading group purchasing organizations.

Endoscopic ultrasound (EUS) is a nonsurgical, minimally invasive procedure that uses high-frequency sound waves to produce detailed images of the gastrointestinal tract and adjacent organs, including the pancreas, liver, bile duct and mediastinal space. To complement EUS, Fine Needle Aspiration (FNA) is often used to collect tissue samples for cancer diagnosis. Data have shown that EUS-FNA procedures are associated with improved survival rates for patients with pancreatic cancer due to more informed, stage-appropriate disease management.¹

"I'm passionate about EUS-FNA because it's a great way to biopsy tissue and get a diagnosis very quickly and minimally invasively," said Ann M. Chen, MD, Director of Endoscopic Ultrasound, Stanford University School of Medicine. "Boston Scientific approached me during the development process for the Expect Slimline Needle and was very receptive to my comments. It's been very gratifying to see that the company cares about physician feedback and acts on it very quickly."

"Expect Slimline is a high quality device that marries what you feel in the handle to what's happening at the device's tip," said Anand Sahai, MD, MSc (Epid), FRCPC, Professor of Medicine, Chief, Division of Gastroenterology at Centre Hospitalier de l'Universite de Montreal in Montreal Quebec. "This translates into excellent precision and control, which is what you strive for in a device."

Boston Scientific introduced the Expect Endoscopic Ultrasound Aspiration Needle in 2011 and soon followed up with the introduction of the Expect 19gauge Flex Endoscopic Ultrasound Aspiration Needle, a more flexible needle made of Nitinol. The new Expect Slimline (SL) Needle offers a smaller handle profile and a smooth gliding mechanism utilized during tissue sampling. The Control ZONE^™ on the handle has two ergonomically defined areas designed to optimize control during the actuation motion and to accommodate different hand sizes and techniques. All Expect Needles have a sharp needle grind and highly visible echogenic pattern, providing precise guidance and helping to maintain tip visibility.

"Endoscopic ultrasound is one of the fastest growing areas within gastrointestinal endoscopy and physicians are increasingly becoming more sophisticated in their techniques and applications," said David Pierce, president, Endoscopy, Boston Scientific. "As the leader in GI endoscopic devices, we have made it a priority to broaden our product portfolio continually to provide physicians with a variety of device solutions to meet their needs. Bringing the Expect Slimline Needle to market in a very short period of time truly underscores our commitment to listening to customers."  

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world.  As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.  For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

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 markets for our products, clinical trials, product performance and impact, 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 Ngamruengphong, et al. "EUS and survival in patients with pancreatic cancer: a population-based study," Gastrointestinal Endoscopy, 2010. 72 (1) 78-83.

CONTACTS
Media:
Nisha Deo
508-652-5609 (office)
Corporate Affairs & Communications
Boston Scientific Corporation 
nisha.deo@bsci.com  

Investors:
Susie Lisa, CFA
508-652-5345 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com

SOURCE Boston Scientific Corporation