Solyx™

SIS System

Advanced Control

with Micro-Adjustability

The Solyx™ SIS System is a single incision sling system designed to be a potentially more

efficient option in the treatment of stress urinary incontinence. The Solyx System is an innovative

mid-urethral sling system that offers several advancements in delivery and tensioning – all built on

the proven Advantage® Mesh platform. The result is sling placement progress towards reduced risk

and dissection, and a more simplified procedure.

Delivery Device

• Designed to seat carrier where placed

• Ergonomic handle design

Mesh Carrier

• The barb design is intended to track smoothly through tissue

• Snap-fit to delivery device tip is designed to prevent premature carrier slip-off

• Mesh assembly is composed of the proven Advantage Meshpolypropylene material

• Mesh is 9cm long

• Over 750,000 Advantage Mesh implant procedures have beenperformed to datel

Suburethral Portion

De-Tanged Edges

De-tanged Polypropylene Material

Designed to Reduce Irritation - 4cm mid-urethral portion is de-tanged to potentially reduce irritation to the urethral wall

Resists Deformation - The suburethral portion of themesh is de-tanged to potentially resist deformation

Ability to Tighten

− Tensioning by delivery device advancement− Carrier snap-fit on delivery device tip designed to facilitate placement control

Ability to Loosen

− With carrier snap-fit on the delivery device tip, the delivery device is designed to allow retraction if needed

The Single Incision Sling System designed with Micro-Adjustability

Note: Once the carrier is deposited in tissue, it is not designed to be reconnected onto the shaft tip for additional tension/adjustment

Advanced ControlThe Solyx System Carrier Tip allows for

Mid-line marker designed to facilitate guidance

for accurate placement

Mesh assembly placement is designed to be away fromcritical structures, such as

the obturator bundle.

Solyx mesh assembly placed in lateral view

Obturator artery

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All trademarks are the property of their respective owners.

Products shown for INFORMATION purposes only and may not be approved for sale in certain countries. Please check availability with your local sales representative or customer service.

For female Mid-Urethral Slings: CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician trained in the use of surgical mesh for repair of stress urinary incontinence.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France.

Solyx™ SIS System Procedure

1 2 3

4 5 6

Prepare and drape the patient usingstandard surgical practice. Ensure thebladder is empty. Make a 1.0 to 1.5 cmvertical midline incision on the anteriorvaginal wall at the level of the mid-urethra.

Dissect bilaterally to the interior portion ofthe inferior pubic ramus at a 45˚ angle offthe midline creating a pathway for deliverydevice placement.

Place the mesh assembly onto thedelivery device by placing the deliverydevice tip into the mesh carrier. NOTE:The mesh carrier should be pushed ontothe delivery device tip until it is flush withthe end of the delivery device shoulder.While placing the mesh carrier onto thedelivery device, make sure that the meshis oriented so that it lies on the outsidecurve of the delivery device. The mesh is now ready for placement.

Insert the delivery device into thedissection pathway targeting placement of the carrier at a 45˚ angle of the midline.Advance the delivery device towards the obturator foramen just lateral to theinferior pubic ramus until the midline markon the delivery device is approximately at the midline position under the urethra.

Deposit the carrier by gripping thedeployment mechanism with one handand pulling the delivery device handle back with the other hand. This action willdeposit the carrier into the surroundingobturator internus muscle tissue releasingit from the delivery device.

Repeat contralaterally. NOTE: Once thecarrier is deposited in tissue, it is notdesigned to be reconnected onto the shaft tip for additional tension/adjustment.Cystoscopy may be performed at thephysician’s discretion. Close incisionaccording to usual methods.

Ordering Information

M0068507000 Solyx SIS System –(1 Delivery Device and 1 Mesh Assembly)

M0068507001 Solyx SIS System –(Box 5)

Boston Scientific Corporation300 Boston Scientific Way Marlborough, MA 01752www.pelvic-floor-institute.com

Ordering Information1.888.272.1001

© 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

WH-413614-AB SEP 2016