Endoscopic Ultrasound

SharkCore™️ EUS Fine Needle Biopsy (FNB) System

Product Description

The SharkCore™️ EUS Fine Needle Biopsy (FNB) System design allows for consistent, predictable tissue acquisition with intact cellular architecture.^1-5

It streamlines procedures with interchangeable needles whilst maintaining the position of the sheath in the endoscope.^6-8

Order Information

The SharkCore™️ FNB Needle has six distal cutting edge surfaces, designed to increase tissue yield.

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Dr. Haba and Dr. Agudo discuss their experience working with EUS and EUS-guided endoscopy.

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Confidence in your diagnosis

The six distal cutting edges of the SharkCore™️ EUS Fine Needle Biopsy (FNB) System needle are specifically designed to obtain cohesive units of tissue with intact cell architecture. By minimizing tissue stacking and fracturing, the needle can potentially provide better core samples and help gastroenterologists and pathologists make more consistent and definitive diagnoses.^1,2

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Because with patient health, even the smallest details can have a big impact.

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Obtains high-quality and high-quantity tissue samples for accurate diagnosis^9,10
Achieve precision with needles built to target lesions in and near the GI tract^10,11
Streamlines procedures with interchangeable needles whilst maintaining the position of the sheath in the endoscope^6-8
Automatic built-in safety system to reduce the risk of needle stick injury¹²

Quick Reference Guides

The device is used to sample targeted sub-mucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope.

Download the FNA QUick Reference Guide

Download the FNB QUick Reference Guide

Learn more about the procedural overview. Not all necessary procedural steps are depicted in this training material. Please refer to the device Instructions for Use for additional information.

Download the In-Service guide

Clinical Evidence

In memoriam: Fine-needle aspiration, birth: Fine-needle biopsy: The changing trend in endoscopic ultrasound-guided tissue acquisition.

Objective: The aim of the study was to compare fine-needle biopsy (FNB) and fine-needle aspiration (FNA) diagnostic yield for onsite and offsite sample assessment.

Conclusion: This study showed that FNB performed better than FNA for both onsite and offsite evaluation of solid mass lesions.

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Randomized controlled trial comparing the Franseen needle with a Fork-tip needle for EUS-guided fine-needle biopsy

Objective: The goal of this study was to compare the ability of Franseen and Fork-tip needles to provide histologic tissue samples and reach an accurate diagnosis.

Conclusion: Franseen and Fork-tip needles both provide a high yield of histological tissue core sample, with no significant difference in tissue quality or diagnostic accuracy.

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Comparing Needles and Methods of Endoscopic Ultrasound-Guided Fine-Needle

Biopsy to Optimize Specimen Quality and Diagnostic Accuracy for Patients with Pancreatic Masses in a Randomized Trial

Objective: The goal of this study was to compare specimen quality and accuracy of diagnoses from fine-needle biopsy (FNB) needles using different collection techniques.

Conclusion: When compared with samples from 22 gauge reverse bevel and Menghini tip needles, collecting FNB samples using the fork-tip or franseen needle with stylet retraction results in the highest degree of cellularity and provides diagnostics accuracy >90% in patients with suspected pancreatic cancer.

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Achieve a more confident diagnosis with the Beacon™ EUS delivery system.

Diagnosis of some pancreatic diseases, such as well-differentiated adenocarcinomas and autoimmune pancreatitis, may be difficult to achieve with cytologic smears.^13,14

In these cases, the use of ancillary testing is critical to achieve a diagnosis. These tests require a sufficient material sample for processing histologically or as a cell block.

The Beacon™ EUS delivery system helps enhance the content and adequacy of specimens for additional diagnostic testing to improve patient care.

Download the pathologists brochure

The SharkCore™ EUS Fine Needle Biopsy (FNB) System allows for consistent, predictable tissue acquisition with intact cellular architecture^1-5 at the same time, it requires a significantly lower number of passes to achieve an adequate specimen, compared to the standard FNA needle (p value < 0.001)¹⁵.

Clinical evidence suggests that FNB needles could have an important role in the natural evolution of EUS-guided tissue acquisition as a tool for molecular diagnostics on formalin-fixed paraffin-embedded samples for personalized treatments.⁹

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According to the Centers for Disease Control and Prevention and European Agency for Safety and Health at Work reports, there are more than 385,000 and 1,000,000 needle stick injury cases annually among hospital health care workers in the United States and Europe, respectively¹⁶. Needle stick injuries increase the risk of over 20 types of infectious diseases among health care workers, including hepatitis B, hepatitis C, and HIV^.16

The SharkCore™ EUS delivery system is the only EUS device designed with an automatic safety shielding feature to aid in the prevention of needle stick injury to staff.¹²

For additional information or to place an order, please call Customer Service at +44 (0) 19 2320 2504.

Order Code	Product Description	Unit of Measure	Quantity
DSL-19-01	Beacon™ EUS Delivery System with SharkCore™ LG FNB Needle, 19-Gauge, Nitinol	Each	1
L-19-05	SharkCore™ LG FNB, 19-Gauge, Nitinol	Box	5
DSC-22-01	SharkCore™ FNB Biopsy System with Needle, 22-Gauge	Each	1
DSC-25-01	SharkCore™ FNB Biopsy System with Needle, 25-Gauge	Each	1
C-22-05	SharkCore™ FNB Needle, 22-Gauge	Box	5
C-25-05	SharkCore™ FNB Needle, 25-Gauge	Box	5

Order Information

Customer Technical Helpline: 01452 223217
For more information, email: rs.gi-support@medtronic.com

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INTENDED USE

The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.

CONTRAINDICATIONS

Those specific to primary endoscopic procedure to be performed in gaining access to desired site. Coagulopathy.

POTENTIAL COMPLICATIONS

Those associated with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, infection, allergic reaction to medication, damage to blood vessels, nerve damage, and acute pancreatitis. Those associated with EUS Needle Biopsy include but are not limited to: bleeding, pain, death, peritonitis, infection / bacteremia, tumor seeding of the needle tract, and needle fracture requiring intervention for removal.

1. Based on internal testing data, Report #1085 dated July 8, 2014;
2. Report #1090, dated September 25, 2014 (Data on file).
3. Adler AG, Witt B, Chadwik B, Well J, Taylor LJ, et al. Pathologic evaluation of a new endoscopic ultrasound needle designed to obtain core tissue samples: A pilot study. Endosc Ultrasound. 2016 May-Jun; 5(3): 178- 183.
4. DiMaio CJ., et al. Initial Experience with a novel EUS-guided core biopsy needle (SharkCore): results of a large North American multicenter study. Endosc Int Open 2016 Sep;4(9): E974–E979.
5. Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc 2018 Jun;87(6);1432-1438.
6. TR110601 Rev 01 DV Report dated November 11, 2011 (Data on file)
7. James TW, Baron TH. A comprehensive review of endoscopic ultrasound core biopsy needles. Expert Review ofMedical Devices 2018
8. PPQ Report: TR-20009 Rev 01 dated March 9, 2015 (Data on file)
9. Crinò et al. Randomized trial comparing fork-tip and side-fenestrated needles for EUS-guided fine-needle biopsy of solid pancreatic, Gastrointestinal Endoscopy Volume 92, No 3: 2020 lesions
10. Young Bang J, Krall K, Jhala N, et al. Comparing Needles and Methods of Endoscopic Ultrasound-Guided Fine-Needle Biopsy to Optimize Specimen Quality and Diagnostic Accuracy for Patients with Pancreatic Masses in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Apr; 19 (4): 825-835. E7. doi: 10.1016/j.cgh.2020.06.042. Epub 2020 Jul 8. PMID: 32652307.
11. Han Samuel et al. Comparative diagnostic accuracy of EUS needles in solid pancreatic masses: a network metaanalysis Endosc Int Open 2021; 09: E853–E862
12. SharkCore^TM Fine Needle Biopsy System IFU Part No. PN1006519
13. Biermann K, Lozano Escario MD, Hébert-Magee S, Rindi G, Doglioni C. How to prepare, handle, read, and improve EUS-FNA and fine-needle biopsy for solid pancreatic lesions: The pathologist’s role. EndoscUltrasound. 2017;6(3):S95–S98.
14. Jovani M. Abidi WM, Lee LS. Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study. Scand J Gastroenterol. 2017;52(6-7):784–787.
15. Kandel P., Tranesh G., Nassar A., Bingham R., Raimondo M., Woodward T.A., Gomez V., Wallace M.B. EUS- guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study. Gastronintest Enosc 2016 DeC; 84(6):1034-1039
16. Bouya S, et al. Global Prevalence and Device Related Causes of Needle Stick Injuries among Health Care Workers: A Systematic Review and Meta-Analysis. Annals of Global Health. 2020; 86(1): 35, 1–8. DOI: https://doi.org/10.5334/aogh.2698)

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Endoscopic Ultrasound

SharkCore™️ EUS Fine Needle Biopsy (FNB) System

Product Description

Order Information

SharkCore™️ FNB System

Animation video

Watch the animation video

What physicians say about EUS

Listen to their testimonial

Confidence in your diagnosis

Ready to go where you need it to go

View Product Brochure

Engineered to do more

Quick Reference Guides

Beacon™ EUS Fine Needle Aspiration (FNA) System

Download the FNA QUick Reference Guide