catalog no. description control. - stryker · entellus medical, inc. 3600 holly lane north, suite...

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Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN, USA 55447 O 866.620.7615 F 763.463.1599 www.EntellusMedical.com www.SinusSurgeryOptions.com 2975-015 rC 11/2017 © 2017 Entellus Medical, Inc. INDICATIONS FOR USE: To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach. Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events as well as cleaning, sterilizing and care for surgical instruments. A physician using XprESS for Eustachian tube dilation must either have: (i) experience with a Eustachian tube balloon dilation device or (ii) undergone cadaver training on the use of a balloon dilation device for Eustachian tube dilation. If a physician who intends to use XprESS for Eustachian tube dilation does not meet at least one of these criteria, please contact your Entellus Medical representative to arrange training. CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. REFERENCES: 1 Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort withlong-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016:126:44-50. 2 Data on File. Entellus Medical, Inc. ENTELLUS MEDICAL, PATHASSIST and XPRESS are trademarks of Entellus Medical, Inc. CATALOG NO. DESCRIPTION ULF-105 XprESS Ultra 5 mm x 20 mm ULF-106 XprESS Ultra 6 mm x 20 mm ULF-205 XprESS Ultra 5 mm x 8 mm ULF-206 XprESS Ultra 6 mm x 8 mm LPLF-105 XprESS LoProfile 5 mm x 20 mm LPLF-106 XprESS LoProfile 6 mm x 20 mm LPLF-107 XprESS LoProfile 7 mm x 20 mm LPLF-205 XprESS LoProfile 5 mm x 8 mm LPLF-206 XprESS LoProfile 6 mm x 8 mm JD-106 XprESS Pro 6 mm x 18 mm JD-107 XprESS Pro 7 mm x 18 mm JD-206 XprESS Pro 6 mm x 8 mm LFLED-100 PathAssist LED Light Fiber LF-100 PathAssist Light Fiber Product Specifics ABOUT ENTELLUS MEDICAL Entellus Medical is a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis in both adult and pediatric patients. www.EntellusMedical.com www.SinusSurgeryOptions.com EXPERIENCE THE POWER OF TOTAL CONTROL. SECUriTY IN NUMBERS. After 10 years and hundreds of thousands of patients treated, balloon dilation has firmly established itself as part of the continuum of care for chronic sinusitis patients and the patient preferred treatment option. IMPACTFUL 24,705 HOURS - 1,029 DAYS saved from exposure to general anesthetic 2 239,788 HOURS - 657 YEARS given back through faster recovery 2 130,793 HOURS - 358 YEARS less time spent on prescription pain medication 2 SUBSTANTIAL Transitioning care to the office has removed OVER $ 300,000,000 in cost (and counting) from the healthcare system 2 Significant symptom RELIEF comparable to FESS, through 24 months 1 LOW REVISION RATE 1 GREATER THAn 97 % SUCCESS RATE PROVEN THE EXPERIENCE THEY DESERVE.

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Page 1: CATALOG NO. DESCRIPTION CONTROL. - Stryker · Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN, USA 55447 O 866.620.7615 F 763.463.1599   2975-015 rC 11/2017

Entellus Medical, Inc.3600 Holly Lane North, Suite 40Plymouth, MN, USA 55447

O 866.620.7615F 763.463.1599www.EntellusMedical.comwww.SinusSurgeryOptions.com

2975-015 rC 11/2017

© 2017 Entellus Medical, Inc.

INDICATIONS FOR USE: To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach.

Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events as well as cleaning, sterilizing and care for surgical instruments.

A physician using XprESS for Eustachian tube dilation must either have: (i) experience with a Eustachian tube balloon dilation device or (ii) undergone cadaver training on the use of a balloon dilation device for Eustachian tube dilation. If a physician who intends to use XprESS for Eustachian tube dilation does not meet at least one of these criteria, please contact your Entellus Medical representative to arrange training.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

REFERENCES: 1Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort withlong-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016:126:44-50. 2Data on File. Entellus Medical, Inc.

ENTELLUS MEDICAL, PATHASSIST and XPRESS are trademarks of Entellus Medical, Inc.

CATALOG NO. DESCRIPTION

ULF-105 XprESS™ Ultra 5 mm x 20 mm

ULF-106 XprESS™ Ultra 6 mm x 20 mm

ULF-205 XprESS™ Ultra 5 mm x 8 mm

ULF-206 XprESS™ Ultra 6 mm x 8 mm

LPLF-105 XprESS™ LoProfile 5 mm x 20 mm

LPLF-106 XprESS™ LoProfile 6 mm x 20 mm

LPLF-107 XprESS™ LoProfile 7 mm x 20 mm

LPLF-205 XprESS™ LoProfile 5 mm x 8 mm

LPLF-206 XprESS™ LoProfile 6 mm x 8 mm

JD-106 XprESS™ Pro 6 mm x 18 mm

JD-107 XprESS™ Pro 7 mm x 18 mm

JD-206 XprESS™ Pro 6 mm x 8 mm

LFLED-100 PathAssist™ LED Light Fiber™

LF-100 PathAssist™ Light Fiber™

Product Specifics

ABOUT ENTELLUS MEDICAL Entellus Medical is a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis in both adult and pediatric patients. www.EntellusMedical.com www.SinusSurgeryOptions.com

EXPERIENCE THE POWER OF TOTAL CONTROL.

SECUriTY IN NUMBERS. After 10 years and hundreds of thousands of patients treated, balloon dilation has firmly established itself as part of the continuum of care for chronic sinusitis patients and the patient preferred treatment option.

IMPACTFUL 24,705 HOURS - 1,029 DAYS saved from exposure to general anesthetic2

239,788 HOURS - 657 YEARS given back through faster recovery2

130,793 HOURS - 358 YEARS less time spent on prescription pain medication2

SUBSTANTIAL Transitioning care to the office has removed

OVER $300,000,000 in cost (and counting) from the healthcare system2

Significant symptom

RELIEF comparable to FESS, through

24 months1

LOW REVISION RATE1

GREATER THAn

97% SUCCESS

RATE

PROVEN

THE EXPERIENCE THEY DESERVE.

Page 2: CATALOG NO. DESCRIPTION CONTROL. - Stryker · Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN, USA 55447 O 866.620.7615 F 763.463.1599   2975-015 rC 11/2017

BE CONFIDENT WITH FAMILIAR CONTROL. Whether treating in your office or the OR, you need quick feedback you can count on. The sleek seeker-based design of XprESS provides the tactile feel you are accustomed to, and enables easy endoscopic visualization and placement.

GET RESULTS with maximum flexibility. No two patients are the same. Treat multiple sinuses and Eustachian tubes— even in your most complex anatomical cases—with a malleable, easily reshapeable tip and simple bending tool.

FIND THE POWER OF PRECISE PLACEMENT. With XprESS, you have a choice of confirmation methods to enable precise placement. Markings at 1 and 2cm at the device tip help you to visualize placement depth. Real-time red LED light confirmation provides superior transillumination for your sinus patients. And for those sinus patients where atypical or modified anatomy may remove traditional landmarks, XprESS with the Fiagon GuideWire* enables the additional security of image guidance. *not compatible with the XprESS Ultra device

EXPAND YOUR PATIENT POPULATION. Your patients, big and small, count on you for relief. Entellus Medical has the broadest patient indication possible. We have approval for balloon sinus dilation to treat both the frontal and sphenoid sinuses in adolescents (12+) as well as the maxillary sinuses in children (2+). In addition, you can treat ETD patients who are 18+.

FPO

The familiar seeker-based design of the XprESS family of balloon dilation technology enables you to easily and confidently take control in your treatment of your sinusitis and Eustachian tube dysfunction patients and of your schedule.

MAXILLARY

SPHENOID

EUSTACHIAN TUBE

FRONTAL

• Super-sleek profile delivers optimal visualization and enables navigation of small and tight anatomy

• Integrated LED Light Fiber delivers real-time placement confirmation

• Wider lumen allows for enhanced integrated suction and irrigation

• Compatible with Fiagon™ Sinus Navigation System

• Broader range of balloon sizes allows physician to address special case patient needs

• Compatible with Fiagon™ Sinus Navigation System

TIP DIMENSIONS

Frontal Sphenoid 120° Maxillary 11 mm leg length 8 mm leg length 135° Maxillary 11 mm leg length 8 mm leg length

Eustachian tube

BEND OPTIONS

5 X 20 mm 6 X 20 mm 5 X 8 mm 6 X 8 mm

BALLOON SIZES

Integrated LED Light Fiber

LIGHT CONFIRMATION

NA

IMAGE GUIDANCE

TIP DIMENSIONS

Frontal Sphenoid 120° Maxillary 135° Maxillary Eustachian tube

BEND OPTIONS

5 X 20 mm 6 X 20 mm 7 X 20 mm 5 X 8 mm 6 X 8 mm

BALLOON SIZES

Integrated LED Light Fiber

LIGHT CONFIRMATION

Compatible with Fiagon™ Image Guidance

IMAGE GUIDANCE

TIP DIMENSIONS

Frontal Sphenoid 120° Maxillary 135° Maxillary Eustachian tube

BEND OPTIONS

6 X 18 mm 7 X 18 mm 6 X 8 mm

BALLOON SIZES

Add-on Light Fiber available

LIGHT CONFIRMATION

Compatible with Fiagon™ Image Guidance

IMAGE GUIDANCE

1.50 mm1.00 mm

1.75 mm1.25 mm

2.00 mm1.50 mm

3 OPTIONS. 1 Goal. YOU IN CONTROL.The familiar seeker-based design of the XprESS family of balloon dilation technology enables you to easily and confidently take control in your treatment of your patients and of your schedule.

The CONTROL you want. The VERSATILITY you need.