Relieva Spin Balloon Sinuplasty System ® RELIEVA LUMA SENTRY ™ SINUS ILLUMINATION SYSTEM traumatic and flexible guidewire A to safely navigate tortuous anatomy SIMPLICITY Single, unified system to access, dilate, and irrigate BALLOON SLIDER Advance and retract the Sinus Balloon Catheter Easy to set up and use Smooth irrigation exchange SINUS BALLOON CATHETER ilate sinus ostia with the integrated D 5x16 mm or 6x16 mm balloon ndoscopic markers aid visualization E and balloon placement WIRE SPINNER & WIRE SLIDER Spin, advance and retract Relieva Luma Sentry™ Sinus Illumination System SINGLE-HANDED CONTROL Complete control in one hand Precisely position the Sinus Guide Catheter Tip Simply steer the Relieva Luma Sentry™ Sinus Illumination System with your thumb PROVEN SAFETY AND OUTCOMES1,2,3 Flexible over the wire technology for safe sinus navigation and confirmation SINUS GUIDE CATHETER TIPS Designed to access various sinus anatomy Designed to reach and dilate the targeted ostia and outflow tract Durable dilation that effectively restores sinus drainage and function SUCTION CONTROL Cover to increase suction flow rate Relieva Vortex ® 2 SINUS IRRIGATION CATHETER Side and distal jets designed to clear sinus contents Flexible, atraumatic catheter designed for smooth delivery through tortuous anatomy Endoscopic markers aid visualization and placement REFERENCES: 1. Weiss R, Church C, et al. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow up. Otolaryngology Head and Neck Surg. 139:S38-S46, 2008. 2. Levine H, et al. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Annals of Otology, Rhinology & Laryngology. 117(4):263-270, 2008. 3. Karanfilov B, et al. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 3:404–411, 2013. SINUS GUIDE CATHETER TIPS M-110C M-110 5x16 mm F-70 S-0 6x16 mm THE Relieva Spin BALLOON SINUPLASTY SYSTEM IS INDICATED TO ACCESS AND DILATE ADULT AND PEDIATRIC1 SINUSES AND SPACES ASSOCIATED WITH THE PARANASAL SINUS CAVITIES. ® Catalog Number Description RS0516F 5x16 mm Relieva ® Spin Balloon Sinuplasty System, Frontal RS0516M 5x16 mm Relieva ® Spin Balloon Sinuplasty System, Maxillary (Includes RSM110C) RS0616F 6x16 mm Relieva ® Spin Balloon Sinuplasty System, Frontal RS0616M 6x16 mm Relieva ® Spin Balloon Sinuplasty System, Maxillary (Includes RSM110) RSF70 Relieva ® Spin Balloon Sinuplasty System Sinus Guide Catheter Tip, Frontal RSM110C Relieva ® Spin Balloon Sinuplasty System Sinus Guide Catheter Tip, Maxillary Compact RSM110 Relieva ® Spin Balloon Sinuplasty System Sinus Guide Catheter Tip, Maxillary RSS0 Relieva ® Spin Balloon Sinuplasty System Sinus Guide Catheter Tip, Sphenoid RV02 Relieva Vortex ® 2 Sinus Irrigation Catheter For children aged 17 and under, the Relieva ® Spin Balloon Sinpulasty System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. 1 For more information on Relieva ® Spin, Relieva Vortex ® 2, and Acclarent, Inc., please contact your Acclarent representative or visit www.acclarent.com. Balloon Sinuplasty System is intended for use by or under the direction of a physician that is trained in the use of Balloon Sinuplasty Technology. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings and precautions associated with these devices. 1525-B O’Brien Drive Menlo Park, CA 94025 U.S.A. t 650.687.5888 650.687.5886 1.877.775.2789 www.acclarent.com [email protected] f © 2014 Acclarent, Inc. All Rights Reserved. MKT02189 Rev. C
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