32041 TTS-110090-9200 90-930090-9100

BARRX™ 90 RFA FOCAL CATHETEREnables physicians to provide primary treatment for short segments of Barrett’s esophagus, including focal areas such as islands and small tongues. The catheter can also be used for secondary treatment after ablation with the Barrx™ 360 RFA balloon catheter or other therapeutic modalities.1-4

· Most popular device amongst the portfolio.

· Provides primary or secondary treatments for smaller areas such as islands or tongues.

· Can be used as a secondary treatment after circumferential ablation or other therapeutic devices.

· Provides easy introduction into upper GI tract.

· Allows positioning within the esophagus and gastroesophageal junction.

· Provides for direct visualization of electrode during procedure.

· Utilizes standard endoscopic technique.

· Moves in 3 axes (lateral, vertical, longitudinal) to assure tissue contact.

Articulation enables flat contact of electrode with targeted tissue.

The Barrx™ 90 RFA focal catheter provides a controlled ablative therapy at a consistent depth. The single-use disposable catheter works with the Barrx™ flex RFA energy generator to deliver the appropriate level of energy to remove diseased tissue and reduce the risk of damaging underlying healthy tissue.5-8

The Barrx™ radiofrequency ablation system includes an ever-evolving family of balloon catheters for treating large areas of disease, and focal catheters for treating smaller areas such as islands and tongues, and for residual disease touch-up.

Shown left to right: Barrx™ 360 RFA balloon catheter, Barrx™ ultra long RFA focal catheter, Barrx™ 90 RFA focal catheter, Barrx™ 60 RFA focal catheter and Barrx™ channel RFA endoscopic catheter

Barrx™ 90 RFA Focal Catheter

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. Complications observed at a very low frequency 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. References: 1.van Vilsteren FG, Pouw RE, Seewald S, et al. Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett’s oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial. Gut. 2011;60:765-773. 2. Okoro NI, Tomizawa Y, Dunagan KT, et al. Safety of prior endoscopic mucosal resection in patients receiving radiofrequency ablation of Barrett’s esophagus. Clin Gastroenterol Hepatol. 2012;10:150-154. 3. Bulsiewicz WJ, Kim HP, Dellon ES, et al. Safety and efficacy of endoscopic mucosal therapy with radiofrequency ablation for patients with neoplastic Barrett’s esophagus. Clin Gastroenterol Hepatol. 2013;11:636-642 4. Dunn JM, Banks MR, Oukrif D, et al. Radiofrequency ablation is effective for the treatment of high-grade dysplasia in Barrett’s esophagus after failed photodynamic therapy. Endoscopy. 2011;43:627-630. 5. Fleischer DE, Overholt BF, Sharma VK, et al. Long-term (2.5 Year) follow-up of the AIM-II Trial for ablation of Barrett’s esophagus: results after primary circumferential ablation followed by secondary focal ablation. Gastrointest Endosc. 2007;65(5):AB135. Abstract S1292. 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(1):125-30. 7. 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. Gastrointestinal Endoscopy. 2004;60(6):1002-10. 8. 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. Surgical Endoscopy. 2007;21(4):560-9.

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THE BARRX™ RADIOFREQUENCY ABLATION SYSTEMComponents and Accessories

Barrx™ Flex RFA Energy GeneratorProprietary RF energy generator automates the sizing procedure, sets the ablation parameters and supplies energy to the Barrx™ 360 RFA balloon catheter and Barrx™ 90 RFA focal catheter.

Barrx™ 90 RFA Focal CatheterRF bipolar electrode array delivers energy to targeted smaller areas of tissue.

· Single patient use ablation catheter fits on distal end of a flexible endoscope

· Recommended endoscope sizes: 8.6 mm to 12.8 mm

· Electrode dimensions: 20 mm length x 13 mm width

· Catheter shaft working length: 160 cm

· Catheter shaft diameter: 4 mm

Barrx™ RFA CartDesigned to accommodate the Barrx™ flex RFA energy generator.

· Overall dimensions: Height, 42.5"; Width, 22.5" (34" w/trays); Depth, 23"

· Net Weight: 100 lbs.

20 mm

Treatment area footprint (left to right): Barrx™ ultra long RFA focal catheter, 90 RFA focal catheter, 60 RFA focal catheter, and the channel RFA endoscopic catheter

Part Number: 1190A-115A

Part Number: 90-9100

Part Number: CART-100