Tuesday, 10 May 2011 03:09
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."
(1) Ngamruengphong, et al. "EUS and survival in patients with pancreatic cancer: a population-based study," Gastrointestinal Endoscopy, 2010. 72 (1) 78-83.