1. Barrx™ Radiofrequency Ablation System
In-service

2. Agenda Our vision Barrett’s esophagus RFA for Barrett’s esophagus
Society guidelines
Barrx™ radiofrequency ablation system
Treatment protocol
Barrx™ 360 express RFA balloon catheter Procedure
Barrx™ 90, 60 & ultra long focal catheter Procedure
Barrx™ channel RFA endoscopic catheter Procedure
Procedure assistance tools
Barrx™ Radiofrequency Ablation System In-Service

3. our Vision

4. our Vision
Our mission is to alleviate pain, restore health, and extend life.
We maintain a global focus in an effort to address inequities in healthcare access around the world.
Together with our partners, we are leading the creation of value-based healthcare solutions.
Barrx™ Radiofrequency Ablation System In-Service

5. Barrett’s esophagus

6. What is Barrett’s Esophagus?
Barrx™ Radiofrequency Ablation System In-Service

7. Cause of Barrett’s Esophagus
Barrett’s esophagus tissue
Cause of Barrett’s Esophagus
If left untreated, GERD can lead to Barrett’s esophagus.1 Barrett's esophagus is a precancerous disease.
The cells of the esophageal lining change due to exposure to stomach acid.1
Results in formation of intestinal metaplasia (Barrett’s esophagus).
Introduce the audience to Barrett’s esophagus. Explain “dysplasia” in layman’s terms; when GERD is left untreated, acid exposure begins to change the cells of the esophagus.
Point out that Barrett’s esophagus is considered a precancerous disease and begin to introduce the idea of the disease progression. The audience should begin to see how these diseases are related. GERD may seem like a harmless disease, but it can lead to Barrett’s esophagus, which can in turn lead to esophageal cancer.
Complications of Heartburn and GERD. WebMD. Available from: Last accessed: 05/04/2018
Barrx™ Radiofrequency Ablation System In-Service

8. Serious Disease Progression
Barrett’s esophagus
Barrett’s esophagus can progress to esophageal cancer, making timely diagnosis and treatment beneficial.1
Use this slide to provide greater detail about the progression of disease.
Tell the audience that this progression makes timely diagnosis and treatment of GERD or Barrett’s esophagus essential. Delays in diagnosis can allow the disease to progress to esophageal cancer—one of the deadliest forms of cancer.
Normal, healthy esophagus
Esophagus damaged by prolonged acid exposure
Barrett’s esophagus tissue
Dysplastic Barrett’s esophagus
Esophageal cancer
Complications of Heartburn and GERD. WebMD. Available from: Last accessed on June 29th, 2018
Barrx™ Radiofrequency Ablation System In-Service

9. An Increasingly Common Form of Cancer
Esophageal adenocarcinoma (EAC) is the most common type of esophageal cancer and is growing in the U.S.1,2
Tell your audience that this graph illustrates how esophageal cancer rates have increased faster than several other cancers.
Consider explaining how the increasing rates of esophageal cancer are related to other public health trends—namely, increasing obesity rates.
Fig. 1. Relative change in incidence of esophageal adenocarcinoma and other malignancies (1975–2001). Data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program with age-adjustment using the 2000 U.S. standard population. Baseline was the average incidence between 1973 and Solid black line = esophageal adenocarcinoma; short dashed line = melanoma; line = prostate cancer; dashed line = breast cancer; dotted line = lung cancer; dashes and dotted line = colorectal cancer.
Pohl H, Welch HG. The Role of Overdiagnosis and Reclassification in the Marked Increase of Esophageal Adenocarcinoma Incidence. Journal of National Cancer Institute. 2005;97:
Jennifer Warner, 'Rates of Esophageal Cancer are rising,' 2005 WebMd, 18 January 2015, < Accessed on 18 August 2015.
Barrx™ Radiofrequency Ablation System In-Service

10. RFA for Barrett's esophagus

11. Treatment for Barrett’s Esophagus
Radiofrequency ablation (RFA) can be an effective treatment for Barrett's esophagus -when detected early. 1 RFA is a procedure in which heat is used to remove the tissue affected by Barrett’s esophagus.
1. Shaheen NJ, Sharma P, Overholt BF, Wolfsen, Sampliner RE, Wang KK, et al. Radiofrequency Ablation in Barrett’s Esophagus with Dysplasia. New England Journal of Medicine May;360(22):
Barrx™ Radiofrequency Ablation System In-Service

12. High Rate of Complete Response
Clinical evaluations have shown that RFA offers a high rate of successfully removing Barrett’s esophagus.1,2
OVER 90% likelihood of removing precancerous (dysplastic Barrett’s esophagus) tissue from the esophagus.1,2
Describe to your audience how treatment with radiofrequency ablation offers a high chance of successfully removing Barrett’s esophagus.
Make it clear that these results were proven in a clinical study. Point out to the audience that the effectiveness of RFA depends on how far Barrett’s esophagus has progressed, but success rates exceed 90%, even in cases of high-grade dysplasia.1,2
1. Shaheen NJ, Sharma P, et al. Radiofrequency Ablation in Barrett’s Esophagus with Dysplasia. New England Journal of Medicine May;360(22):
2. Phoa K, et al. Radiofrequency Ablation vs Endoscopic Surveillance for Patients With Barrett Esophagus and Low-Grade Dysplasia: A Randomized Clinical Trial. JAMA. 2014;311(12): doi: /jama
Orman ES, Li N, Shaheen NJ. Efficacy and durability of radiofrequency ablation for Barrett's esophagus: systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2013;11:
Phoa K, van Vilsteren FGI,Weusten BLAM, Bisschops R, Schoon EJ, Ragunath K, et al. Radiofrequency Ablation vs Endoscopic Surveillance for Patients With Barrett Esophagus and Low-Grade Dysplasia: A Randomized Clinical Trial. JAMA. 2014;311(12) doi: /jama
Barrx™ Radiofrequency Ablation System In-Service

13. Before and AFTER
Early treatment with RFA can help eradicate Barrett’s esophagus.1, 2,3 The ablation process typically needs to be repeated one or more times for complete response.
BEFORE
Phoa KYN, van Vilsteren FG, Pouw RE, Weusten BL, Schoon EJ, Bisschops R, et al. Radiofrequency Ablation in Barrett's Esophagus With Confirmed Low-Grade Dysplasia: Interim Results of a European Multicenter Randomized Controlled Trial (SURF). Gastroenterology. 2013;144: s-187.
Shaheen NJ, Sharma P, Overholt BF, Wolfsen, Sampliner RE, Wang KK, et al. Radiofrequency Ablation in Barrett’s Esophagus with Dysplasia. New England Journal of Medicine May;360(22):
Wolf  WA, Pasricha S, Cotton C, et al. Incidence of Esophageal Adenocarcinoma and Causes of Mortality after Radiofrequency Ablation of Barrett's esophagus. Gastroenterology. 2015;149:
AFTER
Barrx™ Radiofrequency Ablation System In-Service

14. Society Guidelines

15. The 2011 AGA Medical Position Statement
Suggests RFA as an Option for LGD and select im Patients
LGD Management: “Endoscopic eradication therapy with RFA should also be a therapeutic option for treatment of patients with confirmed LGD in BE”.
Consider RFA for Patients with IM: “…we suggest that RFA, with or without EMR, should be a therapeutic option for select individuals with NDBE who are judged to be at increased risk for progression to HGD or cancer”.
Spechler SJ, Sharma P, Souza RF, Inadomi JM, Shaheen NJ, Allen JI, et al. American Gastroenterological Association Medical Position Statement on the Management of Barrett’s Esophagus. Gastroenterology. 2011;140:
Barrx™ Radiofrequency Ablation System In-Service

16. The 2018 ASGE endoscopic eradication therapy (EET) for BE guideline
Suggests eet for dysplasia
Low Grade Dysplasia Management:
“In BE patients with LGD, we suggest EET compared with surveillance”
High Grade Dysplasia Management:
“ In BE patients with HGD, we recommend EET compared with surveillance”
Non-Dysplastic Barrett’s Esophagus: “Risk stratification and the development of reliable and objective predictive models to identify those NDBE and LGD patients most likely to progress and benefit from EET is critical”
Wani S. Qumseya B, et al. ASGE Standards of Practice Committee. Endoscopic eradication therapy for patients with Barrett’s esophagus-associated dysplasia and intramucosal cancer. Gastrointestinal Endoscopy Volume 87, No
Barrx™ Radiofrequency Ablation System In-Service

17. The 2015 ACG Clinical Guideline:
Diagnosis and Management of Barrett’s Esophagus
“For patients with confirmed LGD and without life- limiting comorbidity, endoscopic therapy is considered as the preferred treatment modality, although endoscopic surveillance every 12 months is an acceptable alternative”. “Patients with BE and confirmed HGD should be managed with endoscopic therapy unless they have life-limiting comorbidity”. “In patients with dysplastic BE who are to undergo endoscopic ablative therapy for nonnodular disease, radiofrequency ablation is currently the preferred endoscopic ablative therapy”.
1. Shaheen NJ, Falk GW, Iyer PG, Gerson L. ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus. Am J Gastroenterol. 3 November 2015; doi: /ajg
Barrx™ Radiofrequency Ablation System In-Service

18. Acg guidelines 2015: diagnosis and management of be
Management of non-nodular BE Therapeutic algorithm
FLAT COLUMNAR MUCOSA
NDBE
REPEAT EGD W/BIOPSIES IN 3-5 YR
INDEFINITE FOR DYSPLASIA (if confirmed after optimized PPI)
EGD W/BIOPSIES IN 1 YEAR
CONFIRMED LGD
ENDOSCOPIC ERADICATION THERAPY
CONFIRMED HGD
T1A EAC*
SYSTEMATIC COLD BIOPSY
* The above schema assumes that the T1a esophageal adenocarcinoma (EAC) displays favorable characteristics for endoscopic therapy, including well-differentiated histology and lack of lymphovascular invasion.
1. Shaheen NJ, Falk GW, Iyer PG, Gerson L. ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus. Am J Gastroenterol. 3 November 2015; doi: /ajg
Barrx™ Radiofrequency Ablation System In-Service

19. Barrx™ Radiofrequency Ablation System Indications, contraindications, risks & product

20. Barrx™ RFA System Catheters
Indications for use
The catheters are indicated for use in bleeding and non-bleeding sites in the gastrointestinal tract including, but not limited to, the esophagus.
Indications for the circumferential catheters include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett’s Esophagus, Dieulafoy Lesions, and Angiodysplasia.
Indications for the focal catheters include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett’s Esophagus, Dieulafoy Lesions, and Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
Barrx™ 90/ultra long/60 RFA focal catheter, Barxx™ channel RFA endoscopic catheter, and Barrx™ 360 express RFA balloon catheter instructions for use
Barrx™ Radiofrequency Ablation System In-Service

21. Barrx™ RFA System catheters
Contraindications
Contraindications for RFA include:
Pregnancy
Prior radiation therapy to the esophagus
Esophageal varices at risk for bleeding
Prior Heller myotomy
Eosinophilic Esophagitis
Contraindications for bleeding & non-bleeding sites in the GI tract include:
Presence of gastric or colorectal ulcers
History of anal incontinence
Presence of anorectal fistulae
Pelvic irradiation within the last 6 months
Barrx™ 90/ultra long/60 RFA focal catheter, Barxx™ channel RFA endoscopic catheter, and Barrx™ 360 express RFA balloon catheter instructions for use
Barrx™ Radiofrequency Ablation System In-Service

22. Barrx™ Radiofrequency ablation System catheters
Procedure 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 acute bleeding, stricture, formation requiring dilation, major bleeding, and transfusion secondary to major bleeding, perforation of the stomach, esophagus, or pharynx, surgery to correct perforation, infection, pleural effusion, arrhythmia, aspiration, and death.
Please refer to the product instructions for use for detailed information.
Barrx™ 90/ultra long/60 RFA focal catheter, Barxx™ channel RFA endoscopic catheter, and Barrx™ 360 express RFA balloon catheter instructions for use
Barrx™ Radiofrequency Ablation System In-Service

23. How Barrx™ rfa catheters work
Innovative Array Technology
Controls depth of energy delivery, reducing risk of stricture formation1-6
Maximizes effectiveness without significant injury to the underlying tissue and allows for the re-growth of healthy tissue1-6
Controlled application of energy uniformly removes the epithelium, reducing potential for buried glands and improving patient tolerability1-6
MAGNIFIED ELECTRODE
Ganz RA, Utley DS, Stern RA, Jackson J, Batts KP, Termin P. Complete ablation of esophageal epithelium with a balloon-based bipolar electrode: a phased evaluation in the porcine and in the human esophagus. Gastrointest Endosc. 2004;60(6):
Dunkin BJ, Martinez J, Bejarano PA, Smith CD, Chang K, Livingstone AS, et al. Thin-layer ablation of human esophageal epithelium using a bipolar radiofrequency balloon device. Surgical Endoscopy. 2006;20:
Smith CD, Bejarano PA, Melvin WS, Patti MG, Muthusamy R, Dunkin BJ. Endoscopic ablation of intestinal metaplasia containing high-grade dysplasia in esophagectomy patients using a balloon-based ablation system. Surg Endosc. 2007;21:
Sharma VK, Wang KK, Overholt BF, Lightdale CJ, Fennerty MB, Dean PJ, et al. Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett’s esophagus: 1-year follow-up of 100 patients. Gastrointest Endosc. 2007;65(2):
Fleischer DE, Overholt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, et al. Long-term (2.5 year) follow-up of the AIM-II trial for ablation of Barrett esophagus: results after primary circumferential ablation followed by secondaryfocal ablation. Gastrointest Endosc. 2007;65:AB135.
Fleischer DE, Overholdt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, et al. Endoscopic radiofrequency ablation for Barrett’s esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy. 2010;42:
ELECTRODES CLOSELY SPACED
Barrx™ Radiofrequency Ablation System In-Service

24. Barrx™ rfa system catheters
Clinical use and goal
Clinical use:
Barrett’s esophagus
Non-nodular Barrett’s esophagus with no dysplasia, LGD, or HGD
Goal:
Delivery of radiofrequency energy allows long or short segments of Barrett’s esophagus to be treated quickly.
Consistent application of bipolar energy uniformly removes the esophageal epithelium, reducing potential for buried glands and improving patient tolerability.1,2
Controlled treatment depth of less than 1,000 μm reduces risk of stricture formation.1
Fleischer DE, Overholt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, et al. Endoscopic ablation of Barrett’s esophagus: a multicenter study with 2.5-year follow-up. Gastrointestinal Endoscopy ;68(5):
Fleischer DE, Overholt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, et al. Endoscopic radiofrequency ablation for Barrett’s esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy. 2010;42:
Shaheen NJ, Sharma P, Overholt BF, Wolfsen, Sampliner RE, Wang KK, et al. Radiofrequency Ablation in Barrett’s Esophagus with Dysplasia. New England Journal of Medicine May;360(22):
Barrx™ Radiofrequency Ablation System In-Service

25. Barrx™ flex RFA Energy Generator
Barrx™ RFA System
Barrx™ flex RFA Energy Generator
Balloon Diameter
Indicates diameter of esophagus as measured by the Barrx™ 360 express
Balloon Pressure
Indicates pressure level in the automatic inflation system
Energy Density
Automatically selects and displays energy setting for connected catheter
Barrx™ 360 express : 10 J/cm2
Barrx™ channel and focal : 12J/cm2
Inflation/Deflation Control
Allows inflation or deflation of the Barrx™ 360 express catheter
Power Display
Automatically selects and displays catheter RF power setting
Auto Inflation
Footswitch
RF Power
Reset Button
Clears operational and recoverable codes
System Status
Displays instructions, error and operational codes with messages
Output Connector Quick release connector
Pneumatic Line Connector
Easy, robust, push-and-click connector
RF Power Control
Starts and stops the output of radiofrequency energy
NOTE: For complete details on the Barrx™ flex RFA energy generator, please refer to the Barrx™ Flex RFA System User Manual
Barrx™ Radiofrequency Ablation System In-Service

26. Barrx™ RFA System Ablation catheters Catheter Specifications
Product Codes
Barrx™ 360 express RFA balloon catheter
Balloon length: 8cm
Electrode length: 4cm
Catheter shaft diameter: 7mm
Catheter shaft working length: 8.5cm
Max number of ablations: 16
64082
BARRX™ channel RFA endoscopic catheter
Recommended scope sizes: endoscopes with working channel diameter of 2.8mm or larger
Electrode: 15.7mm length – 7.5mm width (when ”wings” are unfolded)
Catheter shaft diameter: 2.5mm
Catheter shaft working length: 135cm
Max number of ablations: 120
TTS-1100
BARRX™ 60 RFA focal catheter
Recommended scope sizes: 8.6mm to 9.8mm
Electrode: 15mm length – 10mm width
Catheter shaft diameter: 4mm
Catheter shaft length: 160cm
Max number of ablations: 80
BARRX™ 90 RFA focal catheter
Recommended scope sizes: 8.6mm to 12.8mm
Electrode: 20mm length – 13mm width
Catheter shaft working length: 160cm
BARRX™ ultra long RFA focal catheter
Electrode: 40mm length – 13mm width
Barrx™ Radiofrequency Ablation System In-Service

27. Barrx™ Accessories guidewires
The Barrx™ RFA endoscopic guidewires have been designed to facilitate the exchange of the Barrx™ 360 express RFA balloon catheter. Each single-use guidewire has a coted stainless steel core
BARRX™ RFA Endoscopic Guidewire Model
Description
Specifications
GW-002B
Barrx™ endoscopic guidewire
Outer diameter: 0.038”
Length: 260 cm
Coated, straight, flexible distal tip
GW-005M
Barrx™ endoscopic guidewire, marked
Length: 230 cm
Barrx™ Radiofrequency Ablation System In-Service

28. Barrx™ Accessories Cleaning caps
The Barrx™ RFA cleaning cap is designed to facilitate cleaning of coagulated esophageal tissue. During the treatment protocol for Barrett’s esophagus, cleaning should follow the first ablation
Barrx™ RFA Cleaning Cap Model
Device Compatibility Assessed For Olympus Models
Other Compatible Endoscope Models With Actual Diameter Of…
CP-001A (Small)
GIF-160, GIF-Q180
Between 8.8 mm – 9.7 mm
CP-002A (Medium)
GIF-H180
Between 9.8 mm – 11.1 mm
Barrx™ Radiofrequency Ablation System In-Service

29. treatment protocol BARRX™ 360 EXPRESS RFA BALLOON CATHETER PROCEDURE

30. Sample procedural responsibilities for staff:
Similar to other upper gi procedures
Sedation, positioning, and vital signs monitoring
Airway management
Record keeping
Equipment set-up prior to and during the procedure
Assist with proper guidewire management and catheter placement
Provide irrigation when needed
Cleaning of ablation catheter
Patient discharge instructions and follow-up
Circumferential and focal worksheet samples
Barrx™ Radiofrequency Ablation System In-Service

31. Procedure Supplies: Circumferential
Barrx™ RFA System Supplies:
Circumferential Ablation Procedure
Additional Supplies for Ablation Procedure
Barrx™ flex RFA energy generator
Standard Irrigation:
N-acetlycysteine (Mucomyst) diluted to 1% and mixed in plain water
Plain water irrigation thereafter (do not use saline)
Bite Block with Strap
Barrx™ 360 express RFA balloon catheter
Barrx™ RFA endoscopic guidewire
Barrx™ RFA cleaning cap
Barrx™ Radiofrequency Ablation System In-Service

32. Barrx™ Radiofrequency Ablation System In-Service

33. Example of using a cleaning cap to remove the coagulum after the first set of ablations
The result is a clean ablation zone ready for the second set of ablations
Barrx™ Radiofrequency Ablation System In-Service

34. Barrx™ 360 Express RFA Balloon Catheter:
Procedure Steps
Step 1
Perform endoscopy to identify landmarks; record TIM and TGF.
Irrigate with N-acetylcysteine* (Mucomyst†) (1% in plain water); do not use saline.
(† Mucomyst diluted to 1% (10% Mucomyst solution = 6 cc of Mucomyst and 54 cc of water, 20% Mucomyst = 3 cc of Mucomyst and 57 cc of water).
Suction contents after irrigation is complete.
*Caution: use a 20 ml volume flush at a time, as needed, to avoid risk of aspiration.
Step 2
While the scope is in place, place guidewire. Then remove endoscope leaving guidewire in place.
Step 3
Pass Barrx™ 360 express RFA balloon catheter over guidewire (hyperextension of neck is recommended to ease passage of catheter though oropharyngeal area).
Once catheter is advanced into esophagus, apply gel lubrication and introduce endoscope for direct visualization.
Barrx™ Radiofrequency Ablation System In-Service

35. Barrx™ 360 Express RFA Balloon Catheter:
Procedure steps continued
Step 4
Align the proximal edge of the electrode 1 cm above the TIM. Confirm default energy-density setting of 10 J/cm2.
Step 5
Visually confirm the scope is proximal to top shoulder of balloon. Inflate the balloon by depressing gray pedal on footswitch. Hold suction after balloon is fully inflated, then depress blue pedal on footswitch to deliver ablation energy one time.
Move distally 4 cm and align proximal electrodes with distal end of previous ablation zone. Repeat until distal end of treatment zone overlaps TGF, then ensure that the balloon and electrode are completely deflated with visualization.
Step 6
Disconnect the catheter from the output cable. Rotate catheter clockwise to re-wrap electrode array on balloon.
Maintain visualization with scope at proximal edge of balloon while withdrawing scope and catheter from esophagus. Withdraw endoscope, ablation catheter, and guidewire together as a unit (hyperextension of the neck is recommended during withdrawal).
Step 8
Place Barrx™ RFA Cleaning Cap on endoscope and remove coagulated tissue
Barrx™ Radiofrequency Ablation System In-Service

36. Barrx™ 360 Express RFA Balloon Catheter:
Procedure steps continued
Step 7
Place Barrx™ RFA cleaning cap on endoscope, advance scope to ablated tissue area and remove coagulated tissue with tip of cap.
Step 8
To clean the catheter, inflate the balloon outside of the patient and use a 4x4 gauze dampened in sterile water.
Clean the electrode array in a counter-clockwise direction (in the direction of the electrode array wrap, so as not to uncoil from balloon).
Deflate balloon and set aside until ready for next ablation pass.
Step 9
Repeat ablation process. Prior to reintroduction for second-pass ablation, manually wrap the electrode to reduce overall balloon diameter.
Step 8
Place Barrx™ RFA Cleaning Cap on endoscope and remove coagulated tissue
Barrx™ Radiofrequency Ablation System In-Service

37. Barrx™ 360 Express RFA Balloon Catheter:
Helixing distally
Barrx™ 360 Express RFA Balloon Catheter:
Key points for successful procedures
Intubation/extubation:
Hyperextension of the neck may assist in device intubation and extubation.
“Helixing,” or electrode sheet axial displacement, can occur. Reposition device to obtain proper wrapping.
Upon extubation clockwise rotation may help to keep the electrode tightly wrapped and reduce overall balloon diameter.
Warning: during withdrawal, observe the balloon and electrode for any interaction with the esophageal tissue so as to ensure atraumatic removal.
Balloon inflation takes slightly longer than the legacy Barrx™ 360 RFA balloon catheter:
You will hear pump noise first after stepping on pedal, then inflation “beeps”.
Allow for complete inflation of balloon prior to applying suction, while keeping scope proximal to balloon shoulder.
You want the balloon to inflate and approximate to the esophagus before using suction to assist in tissue apposition.
Helixing proximally
Barrx™ Radiofrequency Ablation System In-Service

38. Treatment Protocol Barrx™ 90, 60 & Ultra long RFA Focal catheter Procedure

39. Procedure Supplies: FOCAL
Barrx™ RFA System Supplies: Focal Ablation Procedure
Additional Supplies for Ablation Procedure
Barrx™ flex RFA energy generator
Standard Irrigation:
N-acetlycysteine (Mucomyst) diluted to 1% and mixed in plain water
Plain water irrigation thereafter (do not use saline)
Bite block with strap
Barrx™ channel RFA endoscope catheter
Barrx™ 90 RFA focal catheter
Barrx™ ultra long focal catheter
Barrx™ 60 RFA focal catheter
Barrx™ RFA cleaning cap
Barrx™ 90 RFA Focal Catheter
Barrx™ Ultra Long Focal Catheter
Barrx™ 60 RFA Focal Catheter
Barrx™ Radiofrequency Ablation System In-Service

40. Barrx™ 90, 60, & Ultra Long rfa focal Catheter
Procedure Steps
Step 1
Perform endoscopy to identify landmarks – Record TIM and TGF.
Irrigate with N-acetylcysteine* (Mucomyst†) (1% in plain water) – do not use saline.
(† Mucomyst diluted to 1% (10% Mucomyst solution = 6 cc of Mucomyst and 54 cc of water, 20% Mucomyst = 3 cc of Mucomyst and 57 cc of water) .
Suction contents, then remove scope.
*Caution: use a 20 ml volume flush at a time, as needed, to avoid risk of aspiration.
Step 2
90/60: Using sterile water, thoroughly wet the Barrx™ 90 or 60 RFA focal catheter strap and the distal end of the scope. Insert the distal end of the scope into the proximal end of the catheter strap.
Barrx™ ultra long RFA focal catheter: Use alcohol to swab the inside of the catheter strap to insert the scope.
Step 3
Advance the scope into the catheter strap until the tip of the scope is aligned with the distal end of the strap.
-Add 60 and Ultra long ( 60 /90 same)
-Ultra -1) 1hit clean 1 hit 2) Insertion of Endo scope into catheter requires Alcohol -
Barrx™ Radiofrequency Ablation System In-Service

41. Barrx™ 90, 60, & Ultra Long rfa focal Catheter
Procedure Steps continued
Step 4
While observing the video endoscopic image on the monitor, rotate the catheter so that it appears at the 12 or 6 o’clock position. If catheter movement resistance is felt, re-wet the catheter and endoscope before attempting to reposition.
Verify the ablation catheter is securely attached to the endoscope before use.
Step 5
Ensure the ablation catheter is attached to the distal end of the endoscope. Advance the scope through the oral cavity with the electrode surface in contact with the tongue.
As the endoscope approaches the larynx and esophageal inlet, the electrode surface is oriented anteriorly.
Step 6
Gently introduce the tip of the ablation catheter posterior to the arytenoids, into the esophageal inlet, avoiding contact with the larynx. Do not use excessive force. Swallowing facilitates passage of the endoscope and ablation catheter.
Barrx™ Radiofrequency Ablation System In-Service

42. Barrx™ 90, 60, & Ultra Long rfa focal Catheter
Procedure Steps continued
Step 7
Advance endoscope and electrode surface to areas of Barrett’s to be treated.
Step 8
Connect the ablation catheter to the output cable.
Check that the energy generator is set to the appropriate default energy setting of 12 J/cm2 to achieve the desired coagulation effect.
Step 9
Target islands and tongues of abnormal tissue first, work proximal to distal, followed by targeting abnormal tissue in the gastroesophageal junction or cardia.
Barrx™ Radiofrequency Ablation System In-Service

43. Barrx™ 90, 60, & Ultra Long rfa focal Catheter
Procedure Steps continued
Step 10
Rotate and linearly position the ablation catheter so that the targetedz tissue is at 12 o’clock in the endoscope view. It should be distal to the tip of the ablation catheter.
Move the catheter to cover the targeted tissue and deflect the endoscope upward (large wheel back). Confirm good contact and deflection of ablation surface.
Step 11
Depress the blue pedal on footswitch (or RF POWER ON/OFF button) to deliver energy. Without moving the ablation catheter, deliver a second ablation when the energy generator displays “Catheter Ready”.
Do not apply a second ablation with the Barrx™ ultra long RFA focal catheter. Inspect for adequate ablation effect. Move on to the next area of targeted tissue.
Barrx™ Radiofrequency Ablation System In-Service

44. Barrx™ 90, 60, & Ultra Long rfa focal Catheter
Procedure Steps continued
Step 12
To treat gastroesophageal junction, position the device with the tip just proximal to the top of the gastric folds, deflecting the endoscope and catheter upward.
Rotate the endoscope and ablation catheter after each ablation set to create a circumferential treatment zone.
Step 13
When all tissue has been treated, use the catheter tip, irrigation and suction to remove all coagulated tissue to provide a clean ablated surface.
Step 14
Disconnect the ablation catheter from the output cable. Remove the endoscope and ablation catheter. Rinse with sterile water and clean the electrode surface with wet gauze.
Step 15
Repeat ablation steps in previously treated areas.
Barrx™ Radiofrequency Ablation System In-Service

45. Treatment Protocol Barrx™ Channel RFA Endoscopic catheter Procedure

46. Barrx™ Channel rfa Endoscopic Catheter
Procedure Steps
Step 1
Pre-load RFA cleaning cap on the distal end of the endoscope.
Perform endoscopy and record landmarks - TIM & TGF.
Irrigate with N-acetylcysteine* (Mucomyst†) (1% in plain water) – do not use saline.
(† Mucomyst diluted to 1% (10% Mucomyst solution = 6 cc of Mucomyst and 54 cc of water, 20% Mucomyst = 3 cc of Mucomyst and 57 cc of water) .
Suction contents.
*Caution: use a 20 ml volume flush at a time, as needed, to avoid risk of aspiration.
Step 2
Remove black plastic introducer from the ablation catheter packaging, and insert the narrow portion of the introducer into the biopsy port of the endoscope.
Step 3
Gently insert the tip of the ablation catheter into the introducer.
The active surface of the electrode should face outward during advancement through the introducer. Slide the copper bars of the electrode along the inner surface of the introducer while advancing the channel catheter.
Barrx™ Radiofrequency Ablation System In-Service

47. Barrx™ Channel rfa Endoscopic Catheter
Procedure Steps continued
Step 4
After introduction, the plastic introducer should be relocated from the biopsy port and attached to the torque break at the distal end of the proximal shaft by sliding the introducer along the catheter shaft .
Caution: leaving the introducer in the biopsy seal will affect the ability to inflate and provide suction with the scope. It will also eliminate the seal at the biopsy valve.
Step 5
Rotation of the catheter electrode may be achieved by torqueing and/or twisting the catheter shaft and moving the endoscope.
Barrx™ Radiofrequency Ablation System In-Service

48. Barrx™ Channel rfa Endoscopic Catheter
Procedure Steps continued
Step 6
Move catheter to desired position with copper electrodes facing the targeted tissue (user will see blue backing).
Position catheter in direct contact with the targeted tissue by deflecting the endoscope (visually confirm apposition of the entire electrode to the tissue).
Ensure that the default energy setting of 12J/cm2 is selected. Depress blue pedal on footswitch to deliver RF energy. Deliver two doses of ablative energy to the targeted area and move to next segment of targeted tissue.
Step 7
Withdraw the catheter into the distal working channel of the endoscope.
Ensure that the catheter folds so that the electrode bars are visible when it enters the working channel of the endoscope.
Caution: Withdrawal of the catheter into the distal working channel with the copper electrodes inverted (incorrect configuration) may lead to higher than expected retraction forces .
Remove catheter from endoscope for cleaning, leaving the endoscope in place.
Correct configuration
Incorrect configuration
Barrx™ Radiofrequency Ablation System In-Service

49. Barrx™ Channel rfa Endoscopic Catheter
Procedure Steps continued
Step 8
To clean the catheter once outside the patient, rinse the electrode surface with sterile water irrigation and clean surface with wet gauze.
Step 9
Use the Barrx™ cleaning cap to remove all coagulum from ablated areas.
Step 10
Reintroduce the catheter into the endoscope and repeat the ablation steps.
Barrx™ Radiofrequency Ablation System In-Service

50. Procedure Assistance Tools

51. Summary review of ablation protocols
CIRCUMFERENTIAL AND FOCAL
Barrx™ Radiofrequency Ablation System In-Service

52. Summary review of ablation protocols
CIRCUMFERENTIAL AND FOCAL worksheets
Barrx™ Radiofrequency Ablation System In-Service

53. Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Rx only. 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 and major acute bleeding, stricture, perforation, cardiac arrhythmia, pleural effusion, aspiration, and infection. Potential complications that have not been observed include: death. Please refer to the product user manual or medtronic.com/gi for detailed information. Contact Customer Service or your Sales Representative for the most up-to-date revision of the package insert.
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Barrx™ Radiofrequency Ablation System In-Service