The six distal cutting edges of the SharkCore™ FNB 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.20
The device is used to sample targeted sub-mucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
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.
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.
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.
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.
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 reversebevel 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.
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.21,22
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.
The SharkCore™ EUS Fine Needle Biopsy (FNB) System allows for consistent, predictable tissue acquisition with intact cellular architecture9,10,11,12 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)13.
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.1
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, respectively14. Needle stick injuries increase the risk of over 20 types of infectious diseases among health care workers, including hepatitis B, hepatitis C, and HIV.14
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.15,16,17,18,19
Customer technical service center for gastrointestinal & hepatology products.
Early detection and treatment of chronic GI diseases and cancers can be key to better outcomes. Discover how we can support you in achieving proactive GI care for your patients.
Contact us to learn more about the clinical applications of SharkCore™ FNB Exchange System.
Risk Information: 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. Please refer to the product user manual or www.medtronic.com/gi for detailed information.
1. 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.
2. 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.
3. Han Samuel et al. Comparative diagnostic accuracy of EUS needles in solid pancreatic masses: a network metaanalysis Endosc Int Open 2021; 09: E853–E862
4. TR110601 Rev 01 DV Report dated November 11, 2011 (Data on file).
5. James TW, Baron TH. A comprehensive review of endoscopic ultrasound core biopsy needles. Expert Review of Medical Devices 2018.
6. PPQ Report: TR-20009 Rev 01 dated March 9, 2015 (Data on file).
7. AA study report: TR-20003 Rev 01 dated March 18, 2015 (Data on file).
8. SharkCoreTM Fine Needle Biopsy System IFU Part No. PN1006519.
9. Based on internal testing data, Report #1085 dated July 8, 2014; and Report #1090, dated September 25, 2014 (Data on file).
10. 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.
11. 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.
12. 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: a case-control study. Gastronintest Enosc 2016 DeC; 84(6):1034-1039.
13. 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.
14. 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).
15. FDA-K 133008 Report REP 1049 dated 03,06,2013 (Data on file).
16. FDA 510(K) K133008_BNX FNA System Safety Feature, dated November 20, 2019.
17. FDA 510(K) K141894_SharkCore FNB System, dated October 6, 2014.
18. FDA 510(K) K152586_Beacon Fine Needle Fiducial System, dated December 30, 2015.
19. FDA 510(k) K142198_BNX FNA System Fiducial Marker indication, dated October 8, 2014.
20. Based on internal testing data, Report #1085 dated July 8, 2014; and Report #1090, dated September 25, 2014 (Data on file).
21. 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.
22. 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.