Boston Scientific Begins U.S. and International Launch of Expectâ„¢ Endoscopic Ultrasound Aspiration Needle
NATICK, Mass., May 9, 2011 /PRNewswire / -- Boston Scientific Corporation (NYSE: BSX) today announced the U.S. and international launch of its Expect™ Endoscopic Ultrasound Aspiration Needle, used for acquiring tissue samples for diagnosing and staging malignancies in organs adjacent to the gastrointestinal tract. The Expect Needle received FDA clearance and CE Mark approval earlier this year and is being marketed in the U.S., Europe and other international markets.
Endoscopic ultrasound (EUS) is a non-surgical, less-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 cytology samples for cancer diagnosis. Data have shown that EUS is associated with improved survival rates for pancreatic cancer patients due to more informed, stage-appropriate disease management(1).
"Combining EUS with FNA offers powerful diagnostic capabilities that can help optimize malignancy management in the GI tract and inform appropriate treatment paths for the patient, including surgery, chemotherapy, radiation or palliation," said Robert H. Hawes, M.D., Professor of Medicine, Division of Gastroenterology and Hepatology, at the Medical University of South Carolina in Charleston. "The excellent visibility, sharpness and durability of the Expect Needle help obtain high-quality diagnostic samples easily and efficiently."
The Expect Needle features an echogenic pattern providing excellent visibility and precise needle guidance within the targeted organ or structure. The cobalt chromium design is engineered to offer improved sharpness and pushability, along with deformation resistance, compared to traditional stainless steel needles. As a result, physicians may be able to more easily and accurately obtain a tissue sample while maintaining excellent visibility during the procedure.
"The quality of tissue samples is critical to accurately assessing malignancies, which in turn impact treatment algorithms," said Shyam Varadarajulu, M.D., Director of Endoscopy, University of Alabama, Birmingham. "The Expect Needle yields detailed, high-quality samples that enable rapid evaluation of lesions and abnormalities to determine the specific stage of malignancies."
"The launch of the Expect Needle broadens our Endoscopy portfolio and further strengthens our leadership position in pancreaticobiliary disease management," said David Pierce, President of Boston Scientific's Endoscopy Division. "Providing physicians with an innovative, durable aspiration needle for EUS-FNA procedures highlights our commitment to delivering a full suite of advanced technologies to diagnose gastrointestinal diseases and help improve patient care."
About Boston Scientific
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: 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, the pancreaticobiliary disease management market and our share of that market, new product launches and launch cadence, regulatory approvals, clinical trials, studies, 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; new product performance; 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.