Boston Scientific Corporation 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."
1 Ngamruengphong, et al. "EUS and survival in patients with pancreatic cancer: a population-based study," Gastrointestinal Endoscopy, 2010. 72 (1) 78-83.