Indications, Safety, and Warnings

Endoscopic Ultrasound

SharkCore™ Fine Needle Biopsy (FNB) System

SharkCore™ 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.

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Overview

Gain confidence in your diagnosis

We understand the importance of adequate tissue samples in the early detection and diagnosis of GI diseases. That’s why we’ve developed an innovative FNB needle that works with the Beacon™ endoscopic ultrasound (EUS) delivery system.

The SharkCore™ fine needle biopsy (FNB) system is designed with a passive (i.e. automatic) safety shielding feature to aid in the prevention of needle stick injury.

SharkCore™ info sheet

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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

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Collect cohesive units of tissue with intact cellular architecture¹
Maximize sample acquisition with six cutting-edge surfaces¹
Minimizes damage to tissue as it is collected, enhancing tissue acquisition and diagnostic yield¹
Support flexibility with 19-, 22-, and 25-gauge needles

Discover the Beacon™ endoscopic ultrasound (EUS) delivery system.

Streamline procedures with pre-loaded, interchangeable needles

Needles built to target lesions in and near the GI tract

Obtain high-quality tissue samples for achieving diagnosis^1,2

GI Portfolio Brochure

Learn more about our product portfolio and the care continuums we impact, as well as how we partner with GIs and their staff.

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Service Plan Brochure

Overview of service coverage for GI products, including Beacon™

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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. 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;4(9): E974–E979.
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;19(4):825–835.e7. doi: 10.1016/j.cgh.2020.06.042. Epub 2020 Jul 8. PMID: 32652307.

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Endoscopic Ultrasound

SharkCore™ Fine Needle Biopsy (FNB) System

Order Information

Overview

Gain confidence in your diagnosis

SharkCore™ info sheet

View Brochure

Order Information

Order Information

SharkCore™ is designed with unique needle-tip geometry.