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Boston Scientific obtains FDA and CE Mark approvals for Expect slimline needle

Boston Scientific has obtained the US Food and Drug Administration (FDA) and CE Mark approvals for its Expect slimline needle for use during endoscopic ultrasound fine needle aspiration (EUS-FNA) procedures.

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The company has designed the Expect slimline needle to collect tissue samples to diagnose and stage malignancies in organs adjacent to the gastrointestinal tract. The product is on contract with four group purchasing organizations.

Boston Scientific launched the Expect endoscopic ultrasound aspiration needle in 2011. Soon after its launch, the company introduced the Expect 19gauge flex endoscopic ultrasound aspiration needle, a more flexible needle made of Nitinol.

Innovative handle design of Expect Slimline needle enables physician preferences for precision, comfort and control when acquiring tissue samples during diagnostic procedures.

The Control ZONE on the handle has two ergonomically defined areas, which are designed to optimize control during the actuation motion and to accommodate different hand sizes and techniques.

Boston Scientific’s Expect needles feature a sharp needle grind and highly visible echogenic pattern, which provide precise guidance and helping to maintain tip visibility.

Boston Scientific Endoscopy president David Pierce noted that endoscopic ultrasound is one of the fastest growing areas within gastrointestinal endoscopy and physicians are increasingly becoming more sophisticated in their techniques and applications.

"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," Pierce added.


Image: Boston Scientific’s Corporate Headquarters in Natick, Massachusetts. Photo: Courtesy of Boston Scientific Corporation