` Case 3:16-cv-03340-D Document 1-1 Filed 12/01/16 Page 110 of 148 PageID 168
`
`Albritton Ex. 2015
`Acclarent, Inc. v. Ford Albritton, IV
`IPR2018-00268
`
`
`
`Spin Balloon Sinuplasty System
`Relieva®
`
`
` Case 3:16-cv-03340-D Document 1-1 Filed 12/01/16 Page 111 of 148 PageID 169
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`SIMPLICITY
`
`
`
` Single, unified system to access, dilate, and irrigate
`
` Easy to set up and use
`
` Smooth irrigation exchange
`
`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
`
`
`
` Designed to reach and dilate the targeted ostia and outflow tract
`
`
`
` Durable dilation that effectively restores sinus drainage and function
`
`BALLOON SLIDER
` Advance and retract the
` Sinus Balloon Catheter
`
`RELIEVA LUMA SENTRY ™
`SINUS ILLUMINATION SYSTEM
`
` Atraumatic and flexible guidewire
`to safely navigate tortuous anatomy
`
`SINUS BALLOON CATHETER
`
` Dilate sinus ostia with the integrated
`5x16 mm or 6x16 mm balloon
`
` Endoscopic markers aid visualization
`and balloon placement
`
`WIRE SPINNER & WIRE SLIDER
` Spin, advance and retract Relieva Luma Sentry™
`Sinus Illumination System
`
`SINUS GUIDE CATHETER TIPS
`
` Designed to access various
`sinus anatomy
`
`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.
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` Case 3:16-cv-03340-D Document 1-1 Filed 12/01/16 Page 112 of 148 PageID 170
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`SINUS GUIDE CATHETER TIPS
`
`M-110C
`
`M-110
`
` F-70
`
`S-0
`
`5x16 mm
`
`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
`
`RS0516M
`
`RS0616F
`
`RS0616M
`
`RSF70
`
`RSM110C
`
`RSM110
`
`RSS0
`
`RV02
`
`5x16 mm Relieva ® Spin Balloon Sinuplasty System, Frontal
`
`5x16 mm Relieva ® Spin Balloon Sinuplasty System, Maxillary (Includes RSM110C)
`
`6x16 mm Relieva ® Spin Balloon Sinuplasty System, Frontal
`
`6x16 mm Relieva ® Spin Balloon Sinuplasty System, Maxillary (Includes RSM110)
`
`Relieva ® Spin Balloon Sinuplasty System Sinus Guide Catheter Tip, Frontal
`
`Relieva ® Spin Balloon Sinuplasty System Sinus Guide Catheter Tip, Maxillary Compact
`
`Relieva ® Spin Balloon Sinuplasty System Sinus Guide Catheter Tip, Maxillary
`
`Relieva ® Spin Balloon Sinuplasty System Sinus Guide Catheter Tip, Sphenoid
`
`Relieva Vortex ® 2 Sinus Irrigation Catheter
`
`1 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.
`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
`f 650.687.5886
`1.877.775.2789
`
`www.acclarent.com
`
`info@acclarent.com
`
`© 2014 Acclarent, Inc. All Rights Reserved. MKT02189 Rev. C
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