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Medtronic / Clinical Solutions / Transform Esophageal Care

Transform Esophageal Care

Early detection and treatment of Gastro-Esophageal Reflux Disease (GERD) is essential, as the disease can lead to serious health problems, including Barrett's esophagus.11

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Difficult to diagnose

Challenging to manage

Esophageal disease patients can have similar symptoms — but their diseases may be different. This means tests aren't always conclusive and treatment isn't always effective:

  • Up to 50 percent of endoscopies for predominant esophageal symptoms are negative.1,2
  • Nearly one-third of patients with suspected PPI-resistant nonerosive reflux disease may have primary esophageal motility disorder.3
  • One in three patients referred with ongoing refractory reflux symptoms while using PPIs doesn’t have GERD.4

Simplify the diagnostic journey

Move beyond symptoms with two simple tests

Our solutions help you objectively evaluate the root cause of esophageal motility disorders and GERD.

Two simple tests can transform how you evaluate esophageal motility disorders and GERD:

  • Endoflip™ impedance planimetry system measures dimensions and pressure in real-time to evaluate suspected esophageal motility disorders. Impedance planimetry of the upper gastrointestinal tract adds meaningfully to diagnostic evaluation and therapeutic decision-making.5
  • Bravo™ calibration-free reflux testing system measures acid levels in the esophagus for up to 96 hours7. Early ambulatory esophageal pH monitoring (in conjunction with endoscopy and manometry) before long-term PPI initiation may help define which patients can avoid PPI use and potentially prevent excess PPI dependence.6

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Endoflip™ impedance planimetry system

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Bravo™ calibration-free reflux testing system

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Clinical Evidence

Learn more about the BravoTM Reflux Testing and the EndoflipTM Impedance Planimetry Systems.

Help your patients

Track their symptoms

Use this printable form to track heartburn, reflux and related symptoms.                                                     

Download Symptoms Tracker

Support them to learn more about GERD

Find downloadable educational materials and frequently asked questions about GERD.

See resources

Your partner in Esophageal Care

Learn how our comprehensive portfolio can help you care for patients across the care continuum — from GERD to Barrett's esophagus.

Explore our product solutions

Speak with a representative

For additional information about the EndoflipTM or BravoTM systems, complete a brief form to speak directly with a Medtronic sales representative.

How we can help you transform the esophageal journey

Indications, Contraindications and Risks

BravoTM Reflux Testing Monitoring System

Indications for Use:

  • The Bravo™ monitoring system is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
  • The Bravo™ reflux capsule can be attached following either endoscopy or manometry.
  • The Reflux/Accuview software application is intended to record, store, view, and analyze gastroesophageal pH data.

Contraindications for the Bravo™ reflux testing system include:

  • Patients with bleeding diathesis, strictures, severe esophagitis, varices or obstructions.
  • Patients with pacemakers or implantable cardiac defibrillators.

The risks of Bravo™ reflux testing system include:

  • Aspiration, tears or perforation in the mucosa, pain or discomfort associated with the capsule, premature detachment, or failure to attach the capsule to the esophagus, which may necessitate endoscopic removal.
  • Gastrointestinal endoscopy: Potential complications include, but are not limited to: perforation, hemorrhage, aspiration, fever or infection, hypertension, respiratory arrest, and cardiac arrhythmia or arrest.
  • Nasal intubation: Potential complications include, but are not limited to: sore throat, discomfort, and nasopharyngeal damage resulting in bleeding and soft tissue damage.

Please refer to the product user manual for detailed information.

Endoflip™ Impedance Planimetry System

Indications for Use:

  • The Endoflip™ System is used in a clinical setting to obtain an estimation of the dimensions and balloon pressure within the alimentary canal.

Contraindications for the Endoflip™ Impedance Planimetry System include:

  • The Endoflip™ System is contraindicated where endoscopy is contraindicated. 
  • The Endoflip™ System is contraindicated for use in patients with actively bleeding varices in the esophagus.

Potential complications of  the Endoflip™ Impedance Planimetry System include:

Allergic reaction, Anaphylaxis, Bleeding, Cardio-respiratory complications, Dental trauma, Infection, Pain, Perforation, Pulmonary aspiration, Vasovagal Response

References:

  1. Laine, Goldmann et al. In the clinic: gastroesophageal reflux disease. Annals of Internal Medicine. 2008 Aug 5; ITC2: 1-16.
  2. Vaezi MF et al. Testing for refractory GERD. ASGE Leading Edge – Volume 2, Number 2. American Society for Gastrointestinal Endoscopy
  3. Kawamura O, Hosaka H, Shimoyama Y et al. Evaluation of proton pump inhibitor resistant nonerosive reflux disease by esophageal manometry and 24-hour esophageal impedance and pH monitoring. Digestion. 2015;91(1):19-25.
  4. Herregods, T. V. K., et al. Patients with refractory reflux symptoms often do not have GERD: Neurogastroenterology & Motility. 2015; 27(9): 1267-1273.
  5. Ahuja NK, Agnihotri A, Lynch KL, et al. Esophageal distensibility measurement: impact on clinical management and procedure length. Diseases Of The Esophagus: Official Journal Of The International Society For Diseases Of The Esophagus. 2017;30(8):1-8.
  6. Triadafilopoulos G, Zikos T, Regalia K, et al. Use of Esophageal pH Monitoring to Minimize Proton-Pump Inhibitor Utilization in Patients with Gastroesophageal Reflux Symptoms. Digestive Diseases And Sciences. 2018;63(10):2673-2680. doi:10.1007/s10620-018-5183-4.
  7. Hasak S, Yadlapati R, Altayar O, Sweis R, Tucker E, Knowles K, Fox M, Pandolfino J, Gyawali CP, Prolonged Wireless pH Monitoring in Patients With Persistent Reflux Symptoms Despite Proton Pump Inhibitor Therapy, Clinical Gastroenterology and Hepatology (2020), doi: https://doi.org/10.1016/j.cgh.2020.01.031.
  8. BravoTM Reflux Testing System Instructions for Use.
  9. EndoflipTM Impedance Planimetry System Instructions for Use
  10. Carlson DA, Kahrilas PJ, Lin Z, et al. Evaluation of Esophageal Motility Utilizing the Functional Lumen Imaging Probe. Am J Gastroenterol. 2016 Dec;111(12):1726-1735.
  11. Zehrai A, Yuksel ES, Vaezi MF. Testing for refractory gastroesophageal reflux disease, ASGE Leading Edge, 2012 Vol 2, No 2, 1-13, American Society Gastroenterology Endoscopy