DSC-22-01

DSC-22-01 SHARKCORE BIO SYS 22G SS NDL

The SharkCore™ fine needle biopsy (FNB) system is used with an ultrasound endoscope for needle biopsy of submucosal lesions, mediastinal masses, and more.

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Indications, Safety, and Warnings

Description

The SharkCore™ FNB needle collects samples with intact cellular architecture.^1,–6 Its unique jaw-like profile and six distal cutting edges^1,4,7–11

Improve diagnostic yield^1–6,8
Collect cohesive units of tissue^1,4,7–11
Funnel samples into the lumen1^,4,7–11
Improve tissue access with a longer tip edge^{†,1,4,7–11}

Achieve consistent, predictable tissue acquisition with intact cellular architecture.^1–5

† Compared to FNA needle tips by decreasing penetration force.

Based on internal Beacon™ Endosopic report. REP-1085 (01) BNX EUS FNB Design Review. 2014.
Based on internal Beacon™ Endosopic report. REP-1090 (01) BNX EUS FNB Design Verification Review. 2014.
Adler DG, Witt B, Chadwick B, Wells J, Taylor LJ, Dimaio C, Schmidt R. 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.
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.
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.
Kandel P, Tranesh G, Nassar A, Bingham R, Raimondo M, Woodward TA, Gomez V, Wallace MB. EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study. Gastrointest Endosc. 2016 Dec;84(6):1034–1039.
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.
Rodrigues-Pinto E, Jalaj S, Grimm IS, Baron TH. Impact of EUS-guided fine-needle biopsy sampling with a new core needle on the need for onsite cytopathologic assessment: a preliminary study. Gastrointest Endosc. 2016;84(6):1040–1046.
Moore JZ, McLaughlin PW, Shih AJ. Novel needle cutting edge geometry for end-cut biopsy. Med Phys. 2012;39(1):99–108.
Based on internal Covidien verification report. TR-20011 (1) SharkCore Design 2014.
Based on internal Covidien report. TR-20007 (1) EUS FNB Core Needle Comparative Test. 2014.

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DSC-22-01 SHARKCORE BIO SYS 22G SS NDL

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DSC-22-01 SHARKCORE BIO SYS 22G SS NDL

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DSC-22-01 DSC-22-01 SHARKCORE BIO SYS 22G SS NDL

DSC-22-01 DSC-22-01 SHARKCORE BIO SYS 22G SS NDL

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Not what you're looking for?

United States

Customer Care Team

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DSC-22-01 SHARKCORE BIO SYS 22G SS NDL

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DSC-22-01 SHARKCORE BIO SYS 22G SS NDL