- The Bravo pH monitoring system with accessories is intended to be used for gastroesophageal pH measurement and monitoring of reflux
- Using the delivery system, the Bravo capsule is positioned and attached in the patient’s esophagus, following either endoscopy or manometry
- The pH software analysis program is intended to record, store, view, and analyze gastroesophageal pH data to diagnose reflux disorders
- The Bravo pH monitoring system has FDA clearance for ages 4 and up
- Bravo pH monitoring is contraindicated in patients with bleeding diathesis, strictures, severe esophagitis, varices, or obstructions
- It is also contraindicated in patients with pacemakers or implantable cardiac defibrillators
Potential complications when using the Bravo pH monitoring system include, but are not limited to, the following events: perforation; premature detachment of the pH capsule; failure of the pH capsule to detach from the esophagus within several days after placement; failure to attach to the esophagus; discomfort associated with the pH capsule; tears in the mucosa; capsule aspiration; capsule retention; and bleeding.
Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
Potential complications associated with endoscopic placement include perforation, hemorrhage, aspiration, fever, infection, hypertension, respiratory arrest, and cardiac arrhythmia or arrest. Potential complications associated with nasal intubation include sore throat, discomfort, and nasopharyngeal damage resulting in bleeding and soft tissue damage.
The capsule contains a small magnet, and patients should not have an MRI study within 30 days of undergoing the Bravo pH test.
This information should not be used as a substitute for medical advice concerning specific diagnosis and treatment.