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BRAVO pH System. System Presentation. pH Monitoring with No Strings Attached. Current Technology and it’s Limitations. Catheter Based Systems: Patient Intolerance Uncomfortable Pharyngeal and Throat Discomfort Runny Nose Artifact Prone Alters Regular Diet and Activity
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BRAVO pH System System Presentation pH Monitoring with No Strings Attached
Current Technology and it’s Limitations Catheter Based Systems: • Patient Intolerance • Uncomfortable • Pharyngeal and Throat Discomfort • Runny Nose • Artifact Prone • Alters Regular Diet and Activity • Requires Manometry
Bravo pH System™ • Catheter-Free pH Monitoring System • pH Capsule attached to the esophageal wall transmits data to pager-sized Receiver • Eliminates uncomfortable 24-hr trans-nasal catheter • Allows normal activities, showering and does not interfere with sleeping pH Monitoring with No Strings Attached
Bravo pH System Components 1) Bravo Calibration Stand 2) Bravo pH Receiver 3) Bravo pH Capsule with Delivery System 4) Bravo pH Capsule 5) Bravo DataLink 6) Lithium AA Battery 7) Calibration Solutions (pH 7.01 & 1.07) 8) POLYGRAM NET pH Testing Application • Optional: Vacuum Pump
Bravo pH Capsule with Delivery System • For trans-nasal or trans-oral placement • Single-Use item • One-handed operation • 100 cm long with working length of 80 cm • Distance marks every 5 cm up to 60 cm Handle Catheter pH Capsule
Bravo pH Capsule with Delivery System • Bravo pH Capsule placed via nose or mouth • Trans-nasal placement relative to manometrically identified LES upper boarder • Trans-orally placement relative to endoscopically identified Scuama-Columnar Junction Flexible Tip pH Capsule
Bravo pH Capsule • pH Capsule measures esophageal pH with Antimony pH sensor • Uses Radio-Telemetry to send data to Receiver • Dimensions: 6 x 6.3 x 26 mm • Contains: suction chamber, locking pin, 2 batteries, PCB, transmitter and pH sensor+ref. pH Capsule
Capsule Attachment Step 1 Position Bravo Capsule Step 2 Apply Suction Step 3 Advance Pin Step 4 Release Capsule Step 5 Begin pH Recording
Bravo pH Receiver • pH Capsule transmits data to pager-sized Receiver • Eliminates uncomfortable 24-hr trans-nasal catheter • Allows showering and does not interfere with sleeping Receiver pH Capsule
Digital Radio-Telemetry • Use Digital Radio-Telemetry • Capsule measures pH every 6 sec and transmits data to receiver every 12 sec • Keep the receiver within 1m to prevent data loss (range up to 3m)
Analysis Software • pH study data uploaded to computer via DataLink • Connects to Serial Port NB: Need own Serial Port as it cannot share with IRda for Digitrapper pH DataLink
POLYGRAM NET pH Testing Application • User friendly Windows® software simplifies pH studies • Report includes comprehensive pH study analysis
Clinicals Study Objectives • Evaluate the Bravo pH Procedure Trans-nasally and Trans-orally • Normal Range for 24/48-Hour pH Monitoring (Nasal & Oral) • Assess the Complication Rates for Bravo pH System • User Interface • Performed at: • University of Southern California (Dr. T.DeMeester) • Cleveland Clinic (Dr. J. Richter) • Northwestern University, Chicago (Dr. P.Kahrillas)
Bravo Performs Clinically - Summary • Bravo Market Studies Confirm/Validate Clinical Performance • Bravo’s Capsule is Comparable to the Conventional Catheter in Quantifying Esophageal pH* • The Bravo “Catheter-Free System” should Lead to Increased Patient Acceptance and Compliance of this Test for GERD* *Christopher Streets, M.D. – DDW 2001
Patient Acceptance* Would you undergo the pH test again? YesNo Bravo 100% 0 Catheter 50% 50% *Christopher Streets, M.D., DDW 2001
A Lot Moderate Slight None Effect on Activities* 0.02 0.03 0.006 N/S 0.05 N/S N/S *Christopher Streets, M.D. – DDW 2001
At Last… Patient and Physician friendly pH Monitoring