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SharkCore™️ EUS Fine Needle Biopsy (FNB) System

Beacon™ FNA Exchange System

Overview

Enhanced Tissue Acquisition

The components of this innovative EUS delivery system are interchangeable, supporting greater efficiency,3 while built-in safety features help protect healthcare staff from needle stick injury. And with advanced needles that help improve biopsy yield2,3, interventional endoscopists and pathologists can potentially increase diagnostic rates.1,3

Understanding Endoscopic Ultrasound-Guided Fine Needle Aspiration and Biopsy (EUS-FNA/FNB)

This program aims to provide an overview of the use of EUS-FNA and FNB in the esophagus as it relates to anatomy, disease state, and patient considerations and is accredited by Educational Dimensions for 1 contact hour CNE credit.

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Technology

One delivery system. Multiple devices.

Engineered to improve clinical workflow by facilitating the passage of multiple needles through a single delivery system, without removing the delivery system.

Automated needle shield

  • Designed to cover needle sharp

Proprietary glide ball

  • Allows for interchangeability of all needle sizes through a universal delivery system
  • Start with one needle size and switch to any other size instantly during the same case, while using one universal delivery system
  • Engages automated needle shield during needle removal
  • Centers needle in catheter for consistent needle trajectory

Needle exchange

  • Engineered for multiple needle exchanges throughout the procedure to improve clinical workflow
  • Ergonomic release button designed for fast, efficient removal of needle

Delivery system with PEBAX

  • Maintains flexibility and durability, reducing needle exposure to endoscope channel while remaining in position at point of interest

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  • 1. Based on product development testing data. Data on file. (See Report #1085 and Report #1090).
  • 2. DDW 2015 Presentations: #935. A Novel EUS-guided Liver Biopsy Needle is Superior to 19-G Core and FNA Needles: Examining the Effect of Needle Design, Number of Excursions, and Variable Suction Parameters on Histologic Yield. Schulman A, Thompson C, Chan W, Ryou M. #Tu1638. Initial experience with a novel EUS-guided core biopsy needle (SharkCore™): a North American multicenter study. DiMaio C, Kolb J, Benias P, et al. #Tu1648. Evaluating The Efficacy of a New FDA Approved EUS Core Biopsy Needle and Different Fine Needle Biopsy (FNB) Techniques To Yield The Best Core Specimen In a Live Porcine Model. Shivangi Kothari S, Kothari T, Zhou Z, et al.
  • 3. Enestvedt B, Maranki, J, Makipour K, Mathur M, Haluszka O. Is Two Better Than One? a Comparison of EUS-FNA Efficiency of Single- vs Multi-Needle Platforms. Gastrointestinal Endoscopy. 2013;77(5S):AB179.
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