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MEDTRONIC GASTROENTEROLOGY pH Monitoring with No Strings Attached System Presentation BRAVO pH System.

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Presentation on theme: "MEDTRONIC GASTROENTEROLOGY pH Monitoring with No Strings Attached System Presentation BRAVO pH System."— Presentation transcript:

1 MEDTRONIC GASTROENTEROLOGY pH Monitoring with No Strings Attached System Presentation BRAVO pH System

2 MEDTRONIC GASTROENTEROLOGY 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

3 MEDTRONIC GASTROENTEROLOGY 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™

4 MEDTRONIC GASTROENTEROLOGY Vision: Bravo Technology at Work

5 MEDTRONIC GASTROENTEROLOGY 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

6 MEDTRONIC GASTROENTEROLOGY pH Capsule Catheter Handle 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 Bravo pH Capsule with Delivery System

7 MEDTRONIC GASTROENTEROLOGY 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 pH Capsule Flexible Tip Bravo pH Capsule with Delivery System

8 MEDTRONIC GASTROENTEROLOGY 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 Bravo pH Capsule

9 MEDTRONIC GASTROENTEROLOGY Step 1 Position Bravo Capsule Step 2 Apply Suction Step 3 Advance Pin Step 5 Begin pH Recording Step 4 Release Capsule Capsule Attachment

10 MEDTRONIC GASTROENTEROLOGY pH Capsule transmits data to pager-sized Receiver Eliminates uncomfortable 24-hr trans-nasal catheter Allows showering and does not interfere with sleeping pH Capsule Receiver Bravo pH Receiver

11 MEDTRONIC GASTROENTEROLOGY 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) Digital Radio-Telemetry

12 MEDTRONIC GASTROENTEROLOGY 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 Analysis Software

13 MEDTRONIC GASTROENTEROLOGY User friendly Windows® software simplifies pH studies Report includes comprehensive pH study analysis POLYGRAM NET pH Testing Application

14 MEDTRONIC GASTROENTEROLOGY FeatureBenefit Catheter-Free Enhances Patient Comfort Eliminates Pharyngeal & Throat Discomfort, not Socially Embarrassing Patients are Less Likely to Miss Work Increases Freedom Patients Carry True Physiologic Data Reduces Chance of Artifact Increases Accuracy Easy to Perform Perform Same Time as EGD Available to All GI Docs Increase Physician Revenue Opportunity Features and Benefits

15 MEDTRONIC GASTROENTEROLOGY FeatureBenefit 48-Hour Study Double the Diagnostic Information Bravo Designed for “Atypical” Patients - ENT, Pulmonary, Chest Pain Patient Acceptance Pre/Post Treatment Clinically Document Therapeutic Outcome or Drug Effectiveness Features and Benefits

16 MEDTRONIC GASTROENTEROLOGY 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) Clinicals Study Objectives

17 MEDTRONIC GASTROENTEROLOGY Bravo Clinicals - Preliminar Normal values Composite Parameters Nasal N=20 Oral N=27 Catheter N=50 Total % time pH < % time pH <4 – upright % time pH <4 – supine Longest reflux episode (minutes) # > 5 min Reflux Episodes # Reflux Episodes DeMeester Composite Score (95 th percentile)

18 MEDTRONIC GASTROENTEROLOGY 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

19 MEDTRONIC GASTROENTEROLOGY Would you undergo the pH test again? YesNo Bravo100% 0 Catheter 50% 50% *Christopher Streets, M.D., DDW 2001 Patient Acceptance*

20 MEDTRONIC GASTROENTEROLOGY None A Lot Moderate Slight N/S Effect on Activities* *Christopher Streets, M.D. – DDW 2001

21 MEDTRONIC GASTROENTEROLOGY At Last… Patient and Physician friendly pH Monitoring


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