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Three interchangeable needles — the FNA, FNB, and FNF — allow for fine needle aspiration, fine needle biopsy, fiducial placement and are designed for improved procedural workflow in one procedure.1-8
Successful management of non-resectable liver tumors is about more than what you remove — it’s about what you leave behind, too.
The Emprint™ ablation system supports your journey from careful planning to predictable success when treating small to medium sized non-resectable liver malignancies. It enables a minimally invasive procedure with:
This technology demonstrates controllable and predictable ablation zones and single digit local recurrence rates clinically.15,17-18
We are committed to delivering educational solutions aimed at helping you achieve procedural and clinical proficiency.
SharkCore - 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.
Beacon - Risk Information: Procedural risks associated with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, infection/fever, bacteremia, allergic reaction to medication, damage to blood vessels, nerve damage, tumor seeding of the needle tract, and acute pancreatitis. For Beacon FNF Only: Those associated with EUS fiducial placement include, but are not limited to: improper fiducial placement, fiducial migration, infection/fever, allergic reaction, local inflammatory foreign body response, minor bleeds, pain, pancreatitis, and needle fracture requiring intervention for removal. Please refer to the product user manual for detailed information.
Barrx - Risk assessment: Risk Information: The following are transient side effects that may be expected after treatment: chest pain, difficulty swallowing, painful swallowing, throat pain, and/or fever. Potential complications include mucosal laceration, minor or major bleeding, endoscopic clipping to manage mucosal laceration or bleeding, perforation of the stomach, esophagus, or pharynx, surgery to manage perforation, esophageal stricture, endoscopic dilation to manage stricture, pleural effusion, transfusion secondary to major bleeding, cardiac arrhythmia, aspiration, infection and death.
Emprint - Risk assessment: The Emprint™ ablation system is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The Emprint™ system is not intended for use in cardiac procedures. Microwave ablation procedures are not recommended for patients with cardiac pacemaker or other implanted electronic devices. Potential risks have not been evaluated. Microwave ablation procedures are not recommended for pregnant patients. Potential risks to the patient and/or fetus have not been established.
TR110601 Rev 01 DV Report Dated November 11, 2011 (Data on file)
PPQ Report: TR-20009 Rev 01 dated March 9, 2015 (Data on File)
AA study report: TR-20003 Rev 01 dated March 18, 2015 (Data on file)
510k study TR100509 Rev 01 dated September 21, 2010 (Data on file).
AA study TR100706 Rev 01 dated January 6, 2011 (Data on file).
AA study TR110716 Rev 01 dated December 16, 2011 (Data on file).
DV/PPQ report: TR110601 Rev 01 dated November 11, 2011 (Data on file).
Based on internal testing data,V-0450-02 (Access DVT Report) dated February 8, 2019 (Data on file).
Internal test report #1085, July 8, 2014 and Internal test report #1090, September 25, 2014 (Data on file).
DiMaio CJ, Kolb JM, Benias PC, 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.
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.
Enestvedt B, Maranki, J, Makipour K, Mathur M, Haluszka O. Is two betterthan one? A comparison of EUS-FNA efficiency of single-vs multi-needle platforms. Gastrointest Endosc. 2013;77(5S):AB179.
Moore JZ, Zhang Q, McGill CS, et al. Modeling of the plane needle cutting edge rake and inclination angles for biopsy. J Manuf Sci Eng 2010;132:051005-1-051005-8.22b.
Kothari S, Kothari T, et al. 234, Endoscopic Ultrasound (EUS)-Guided Fiducial Placement for Stereotactic Body Radiotherapy (SBRT): First Global Experience with a New 22-Gauge “Pre-loaded” EUS Fiducial Needle The American Journal of Gastroenterology, vol 110, Supplement 1 October 2015
De Cobelli F et al. microwave ablation of liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions. Med Oncol(2017)34:49
Takahashi, H., Kahramangil, B., Berber, E. Local recurrence after microwave thermosphere ablation of malignant liver tumors: results of a surgical series. 2018. Surgery. 163:709-713
Vogl et al. Evaluation of microwave ablation of liver malignancy with enabled constant spatial energy control to achieve a predictable spherical ablation zone. International Journal of Hyperthermia, (2018). DOI: 10.1080/02656736.2017.1358408.
Imajo K. et al. New microwave ablation system for unresectable liver tumors that forms large, spherical ablation zones. J Gastroenterol Hepatol. 2018;33(12):2007-2014.