Gastroenterology
GI product portfolio
Innovating for patients
Whether it’s esophageal disease, liver cancer, Crohn’s disease, colorectal disease, or other gastrointestinal diseases, you need solutions that improve patient outcomes.
We're putting patients at the center of our solutions, from artificial intelligence colonoscopy to a minimally invasive vitamin-sized pill, which both aid in the detection of colon polyps. Our solutions are designed to help you detect and treat disease in its early stages — that’s the path to better outcomes.
The GI Genius™ intelligent endoscopy module offers a transformative solution − powered by artificial intelligence − assisting physicians in the detection of colorectal polyps regardless of shape, size, and morphology.1
The HET™ bipolar system uses energy to treat grades I and II hemorrhoids in a non-surgical procedure.
The PillCam™ COLON 2 system is a colon exam in a capsule. Perform a capsule endoscopy procedure, record images, and interpret the results with this system.
Today, patients with esophageal diseases face an increasingly complex journey on their path to better outcomes. Solving this challenge requires a radically simple approach — detect their disease early, and treat it early.
Endoscopy is not enough.
It’s time to transform the standard of esophageal care for your patients. In the United States, 50% of endoscopies for predominant esophageal symptoms are inconclusive. This can lead to a continual cycle of tests and a long road to diagnosis.2
Our comprehensive solutions can assist you in potentially assessing and treating esophageal patients by allowing you to:
Inform patient management
50%
of endoscopies for predominant esophageal symptoms2
are inconclusive
The Endoflip™ 300 impedance planimetry system measures pressure and dimensions in real-time to aid in the evaluation of major motility disorders.3
The Barrx™ radiofrequency ablation system is used to treat Barrett’s esophagus (BE) patients by eradicating Barrett’s epithelium.
The Bravo™ calibration-free reflux testing system is a capsule-based testing system used to determine if acid reflux is causing the patient's symptoms.
Eleview®* submucosal injectable composition is used in gastrointestinal (GI) endoscopic procedures to lift polyps, adenomas, or other GI lesions.
The Esoflip™ dilation catheter is designed for use with the Endoflip™ impedance planimetry system and has a dilation balloon for imaging.
The ManoScan™ ESO high resolution manometry system enables healthcare providers to assess the pressure and motor function of a patient’s esophagus.
We provide predictable tools and treatments so you can optimize your clinical approach for your patients - no matter how complex. We’re committed to partnerships with interventional radiologists, pathologists, oncologists, surgeons, and the GI community for proactive GI care.
Three interchangeable needles — the FNA, FNB, and FNF — allow for fine needle aspiration, fine needle biopsy, and fiducial placement. They are designed for improved procedural workflow in one procedure.4-11
The Beacon™ fine needle aspiration (FNA) system is used to sample targeted submucosal and extramural gastrointestinal lesions through an ultrasound endoscope.
The Beacon™ FNF preloaded needle is used to implant fiducial markers under endoscopic ultrasound (EUS) guidance to radiographically mark soft tissue.
The SharkCore™ fine needle biopsy (FNB) needle is used with an ultrasound endoscope for needle biopsy of submucosal lesions, mediastinal masses, and more.
We’re committed to developing meaningful innovations for GI bleeding and chronic diseases, designed to improve outcomes. We help patients with GI bleeding and chronic diseases by providing technologies to help physicians diagnose and treat their diseases.
The PillCam™ SB 3 system may be used in direct visualization and monitoring of lesions that may be related to Crohn’s disease, obscure bleeding, or iron deficiency anemia not detected by upper and lower endoscopy.
The Barrx™ channel RFA endoscopic catheter delivers radiofrequency ablation through the working channel of a flexible endoscope.
The Barrx™ radiofrequency ablation system is used to treat Barrett’s esophagus (BE) patients by eradicating Barrett’s epithelium.
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 the gastroenterology webpage 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 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.
1. Hassan C, Wallace MB, Sharma P, et al. New artificial intelligence system: first validation study versus experienced endoscopists for colorectal polyp detection Gut 2020;69:799-800.
2. Muthusamy VR, Lightdale JR, Acosta RD et al. ASGE Standards of Practice Committee. The role of endoscopy in the management of GERD. Gastrointest Endosc. 2015:81(6):1305-10.
3. Endoflip™ EF-325N Catheter IFU. PT00124053 Rev A. September 2020.
4. Based on DV report TR110601 rev 01. November 11, 2011. Data on file.
5. Based on PPQ report TR-20009 rev 01. March 9, 2015. Data on file.
6. Based on AA study report TR-20003 rev 01. March 18, 2015. Data on file.
7. Based on 510k study TR100509 rev 01. September 21, 2010. Data on file.
8. Based on AA study TR100706 rev 01. January 6, 2011. Data on file.
9. Based on AA study TR110716 rev 01. December 16, 2011. Data on file.
10. Based on DV/PPQ report TR110601 rev 01. November 11, 2011. Data on file.
11. Based on internal testing data V-0450-02 (Access DVT report.) February 8, 2019. Data on file.
12. Internal test report 1085. July 8, 2014. Data on file.
13. Internal test report 1090. September 25, 2014. Data on file.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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