Boston Scientific Solyx User manual

Product Review for the Purchasing Committee
Solyx™
Single-Incision Sling System
Product Overview
Ordering Information
Regulatory Information
Directions for Use
Clinical/Scientific Data
Reimbursement Guide
1

Product Overview
How can we continue to innovate our
family of mid-urethral slings that have
already been the products of choice for
nearly 800,000 patients? By creating
the same reliable mesh in an easy-to-
see, optical blue color. So whatever your
preferred surgical approach, Advantage™
Blue mesh provides improved visibility
so you can treat your patients with
greater condence.
Trusted polypropylene mesh1
• Mesh thickness: 0.66 mm
• Pore size: 1182 μm
• Fiber size (diameter): 0.15 mm
• Weight: 100 g/m2
Improved visibility.
Evidence based.
• The same mesh properties as
our patented Advantage mesh,
which is documented in more
than 35 publications to date.
• The easy-to-see, optical blue color
helps to improve your visibility
for more accurate intra-operative
sling tensioning and makes it
easier to locate post-operatively.
A smooth,
de-tanged suburethral
portion designed to
maintain its integrity during
tensioning and potentially
reduce irritation to
the urethral wall
Tanged edges
outside of the
suburethral portion
may help to minimize
mesh migration
2Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

Mesh carrier
• The barb design is
intended to track
smoothly through tissue
• Snap-t to delivery
device tip is designed
to prevent premature
carrier slip-o
Delivery device
• Designed to seat
carrier where placed
• Ergonomic handle
Mid-line marker
Designed to facilitate
guidance for accurate
placement
Single-incision approach
The Single Incision Sling System
designed with Micro-Adjustability
• Ability to tighten and loosen as needed
• Carrier snap-t on delivery
device tip is designed to facilitate
control during placement
• Sling is tensioned by delivery device
advancement and retraction
• Mesh assembly is designed to be
placed away from critical structures,
such as the obturator bundle
Note: Once the carrier is deposited in tissue,
it is not designed to be reconnected onto the
shaft tip for additional tension/adjustment
3Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

Fundamental dierence in mesh design philosophy
Solyx™Single-Incision Sling (SIS) System
Product code Description Quantity
M0068507010Solyx™Blue Single Incision Sling System 1 Delivery Device and 1 Mesh Assembly
M0068507000Solyx™Single Incision Sling System 1 Delivery Device and 1 Mesh Assembly
Ordering Information
30x magnication
Feature BSC J&J Coloplast
Pore size (microns)11182 1379 374
Density (g/m2)100 100 70
Elasticity High High Low
Knit pattern Tricot Tricot Warp knit, pillar stitch with inlay
Edge design Tanged2Tanged Sealed
Color Clear and Blue3Blue Clear
Nearly 800,000 Boston Scientic mid-urethral slings
with Advantage™mesh have been implanted.
1. Moalli PA, Papas N, Menefee S, et al. Tensile properties of ve commonly used mid-urethral slings relative to the TVT. Int Urogynecol J Pelvic Floor Dysfunct.
2008 May;19(5):655-63.
2. Heat sealed mid-section
3. Advantage Blue mesh available for Advantage Fit, Advantage, Lynx, Obtryx II and Solyx
4Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

Regulatory Letter
May 11, 2018
Dear Valued Customer,
Thank you for your inquiry regarding the Solyx ™ Blue SIS System. This information is provided in
response to your direct request regarding the regulatory status of these products and may not be used for
any other purpose without the expressed written permission of Boston Scientific.
The Solyx™ Blue SIS System, Catalog M0068507010 is marketed in accordance with USA Food and Drug
Administration (FDA) regulations 21 CFR 878.3300 and 21 CFR 884.4910. The 510K that supports this
product was originally cleared by the FDA on August 27, 2008 via 510(k) K081275 and subsequently updated
on September 28, 2012. On January 1, 2018 the delivery device packaged within the system were reclassified
from a Class I to Class II device requiring clearance by FDA under Specialized Surgical Instrumentation for use
with Urogynecologic Surgical Mesh 21 CFR 884.4910. Therefore, the delivery devices packaged within the
system have been cleared by FDA via 510(k) K172565, December 20, 2017. Attached you will find copies of
the clearance letters.
Please contact your local representative or Boston Scientific directly should you have any additional questions
or require additional information.
Sincerely,
Regulatory Affairs
5Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System
Regulatory Information

Regulatory Letter
January 8, 2018
Dear Valued Customer,
Thank you for your inquiry regarding Boston Scientific product, Solyx SIS™System. This information is
provided in response to your direct request regarding the regulatory status of these products and may not be
used for any other purpose without the expressed written permission of Boston Scientific.
M0068507000
Solyx SIS™System
Single
The Solyx SIS™System is marketed in accordance with USA Food and Drug Administration (FDA)
regulations 21 CFR 878.3300 and 21 CFR 876.4730. The 510K that supports this product was originally
cleared by the FDA on August 27, 2008 via 510(k) K081275 and subsequently updated on September 28,
2012. Attached you will find a copy of the updated clearance letter.
Please contact your local representative or Boston Scientific directly should you have any additional questions
or require additional information.
Sincerely,
Regulatory Affairs
Enclosure
6Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

FDA 510K Clearance Letter
7Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

8Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

Indications for Use Statement
9Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0
50431073-01
Instrucciones de uso 10
Mode d’emploi 19
Gebrauchsanweisung 28
Istruzioni per l’uso 37
Gebruiksaanwijzing 46
Instruções de Utilização 55
2016-10
Solyx™
SIS System
Directions for Use 2
Solyx Blue
SIS System
2
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
Table of ConTenTs
WaRnInG ...........................................................................................3
DeVICe DesCRIPTIon.......................................................................3
InTenDeD Use/InDICaTIons foR Use .......................................3
ConTRaInDICaTIons...................................................................... 3
GeneRal WaRnInG.........................................................................4
PosT PRoCeDURal WaRnInG...................................................... 4
PReCaUTIons....................................................................................4
aDVeRse eVenTs .............................................................................5
HoW sUPPlIeD..................................................................................5
oPeRaTIonal InsTRUCTIons.......................................................5
Prior to Use....................................................................................5
Figure 1: Solyx™ SIS System and Solyx Blue SIS
System...................................................................................... 6
WaRnInG ..........................................................................................6
Steps for Use.................................................................................6
Incision and Dissection............................................................... 6
Figure 2: Dissection Pathway...............................................6
Sling Placement ...........................................................................6
PReCaUTIon...................................................................................... 7
Figure 3: Mesh Assembly Placement onto Delivery
Device ......................................................................................7
Figure 4: Mesh Orientation on Delivery Device.................7
WaRnInG ...........................................................................................7
Figure 5..................................................................................... 8
Figure 6..................................................................................... 8
Figure 7..................................................................................... 8
Figure 8: Contralateral Delivery Device Placement..........9
WaRRanTY ........................................................................................9
Directions for Use
Dual manufactured product; no change in content as of January 22, 2018.
For current version refer to the DFU packaged with the product.
10Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

3
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
onlY
Caution: Federal Law (USA) restricts this device to sale by or
on the order of a physician trained in use of surgical mesh for
repair of stress urinary incontinence.
WARNING
Contents supplied STERILE using an ethylene oxide (EO)
process. Do not use if sterile barrier is damaged. If damage is
found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination
of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government policy.
WARNING
This product is intended for use only by clinicians with adequate
training and experience in the surgical treatment of stress
urinary incontinence (SUI). The physician is advised to consult
the medical literature regarding techniques, complications and
hazards associated with the intended procedures.
DEVICE DESCRIPTION
The Solyx and Solyx Blue SIS (Single Incision Sling) Systems
are sterile single use systems each consisting of one (1) delivery
device and one (1) mesh assembly. The mesh assembly is
comprised of a polypropylene knitted mesh with polypropylene
carriers at each end of the distal mesh. The carrier is designed
to be placed on the tip of the delivery device. The disposable
delivery device consists of a handle, a stainless steel shaft
and a deployment mechanism. The delivery device is designed
to facilitate the passage of the mesh assembly through bodily
tissues for placement into the obturator internus muscle.
INTENDED USE/INDICATIONS FOR USE
The mesh implant is intended for use as a suburethral sling
for the treatment of stress urinary incontinence resulting from
urethral hypermobility and/or intrinsic sphincter deficiency.
CONTRAINDICATIONS
A mesh implant is contraindicated in the following patients:
• Pregnant patients, patients with the potential for future
growth or patients who are considering future pregnancies.
• Any patients with soft tissue pathology into which the
implant is to be placed.
• Patients with any pathology which would compromise
implant placement.
• Patients with any pathology that would limit blood supply or
infections that would compromise healing.
Solyx™
SIS System
Solyx Blue
SIS System
4
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
GeneRal WaRnInG
The risks and benefits of performing a suburethral sling procedure
in the following patients should be carefully considered:
• Careful consideration should be given to performing this
procedure for patients with untreated coagulopathies
or who are being treated with either anticoagulants or
antiplatelet agents.
• Patients with hypertonic bladders or vesico ureteral reflux
• Take special care in cases of bladder prolapse
because of anatomical distortion. If the patient requires
a cystocele repair, it should be done prior to the
suburethral sling procedure
• Vaginal and urinary tract infection should be treated prior to
a suburethral sling implantation procedure.
• User should be familiar with surgical procedures and
techniques involving nonabsorbable meshes.
• Good surgical practices should be followed for
management of contamination or infected wounds.
• Mesh is considered a permanent implant. Removal of mesh
or correction of mesh related complication may involve
multiple surgeries.
• Complete removal of mesh may not be possible and additional
surgeries may not always fully correct the complications.
PosT PRoCeDURal WaRnInG
• If subsequent infection occurs, follow appropriate medical
intervention practices.
• The patient should be advised that future pregnancies may
negate the effects of this procedure and the patient may
again become incontinent.
PReCaUTIons
• The use of polypropylene mesh in urogynecologic
procedures such as the treatment of stress urinary
incontinence, regardless of the route of delivery
(transvaginal, suprapubic or transobturator), has been
associated with cases of erosion. Erosion has been
reported in bladder, vagina, urethra and ureter, and bowel.
Treatment of the erosion may require surgical removal.
• As with all surgical procedures, certain risk factors are
known to impact patient outcomes in the pelvic floor
which include, but are not limited to, impaired vascularity
(e.g. diabetes, smoking status, estrogen status, pelvic
floor radiation exposure, etc.), age, pelvic floor myalgia,
impaired wound healing (e.g. diabetes, steroid usage,
etc.), or active infection in or near the surgical site. The
above pathophysiologic conditions must be considered
when determining whether the patient is an appropriate
candidate for mesh implantation, either by transvaginal,
suprapubic or transobturator route.
• Standard surgical practices should be followed for the
suburethral sling procedure as well as for the management
of contaminated or infected wounds.
• Bleeding can occur. Check carefully before releasing
patient from the hospital.
• Ensure the mesh is placed tension free under the mid-urethra.
• Use of this device should be done with the understanding
that subsequent infection may require removal of the mesh.
• Physician should determine when it is suitable for each
patient to return to normal activities.
• Patients should be counseled when to resume vigorous
activities (heavy lifting, exercise), and intercourse after
the procedure.
• Should dysuria, bleeding or other problems occur, the patient
should be instructed to immediately contact their physician.
Dual manufactured product; no change in content as of January 22, 2018.
For current version refer to the DFU packaged with the product.
11Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

5
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
• Do not use any mechanical means of contact with the mesh
(such as clips, staples, etc.) within the urethral support region
of the mesh as mechanical damage to the mesh may occur.
• Avoid excessive tension on the mesh during handling.
ADVERSE EVENTS
The following adverse events have been reported due to
suburethral sling placement, but are not limited to:
• As with all implants, local irritation at the wound site and/or
a foreign body may occur.
• Tissue responses to the mesh implant could include:
• erosion/exposure/extrusion of the mesh through the
vaginal or urethral mucosa, bladder wall or other
surrounding tissue
• scarring/scar contracture
• device migration
• fistula formation and inflammation
The occurrences of these events may require surgical
intervention and possible removal of the entire mesh.
• Like all foreign bodies, the mesh may potentiate an
existing infection.
• Excess tension may cause temporary or permanent lower
urinary tract obstruction and retention.
• Allergic reaction has been reported.
• Known risks of surgical procedures for the treatment of
incontinence include:
• pain, ongoing pain (pelvic, vaginal, groin/thigh,
dyspareunia)
• infection
• detrusor instability
• complete failure of the procedure
• voiding dysfunction (incontinence, mild to moderate
incontinence due to incomplete urethral support or due
to overactive bladder)
• bruising, bleeding (vaginal, hematoma formation)
• abscess
• vaginal discharge
• dehiscence of vaginal incision
• edema and erythema at the wound site
• Perforation or laceration of vessels, nerves, bladder or
urethra may occur during placement.
The occurrence of these events may require surgical
intervention. In some instances the response to these events
may persist as a permanent condition after the intervention.
HOW SUPPLIED
The Solyx™ and Solyx Blue SIS Systems are sterile, single use
systems each consisting of one (1) delivery device and one (1)
mesh assembly. Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Store in a cool, dry, dark place. Rotate inventory so that devices
are used prior to the expiration date displayed on package label.
OPERATIONAL INSTRUCTIONS
Prior to Use
The Solyx and Solyx Blue SIS Systems are supplied sterile and are
intended for single patient use only. Carefully examine the system
to verify that neither the contents nor the sterilized package has
been damaged in shipment. DO NOT USE if the sterile barrier or
product is damaged. Immediately return damaged product to
Boston Scientific. The design of both systems allows the operator
a transvaginal route of delivery. See Figure 1 for parts description.
6
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
Delivery device
Delivery
Device Tip
Midline Marker
Deployment
Mechanism Handle
Mesh Assembly
Mesh Carrier
Polypropylene Mesh
Figure 1: Solyx™ SIS System and Solyx Blue SIS System
WARNING
Ensure that the bladder is empty prior to initiating the use of this
product. Ensure that the bladder, urethra and other important
landmarks are properly identified.
Steps for Use
Incision and Dissection
1. Prepare and drape the patient using standard surgical
practice. Ensure the bladder is empty.
2. Make a 1.0 cm to 1.5 cm vertical midline incision on the
anterior vaginal wall at the level of the mid-urethra. Dissect
bilaterally to the interior portion of the inferior pubic ramus
at the 45˚ angle off the midline creating a pathway for
delivery device placement.
3. Dissect bilaterally to the interior portion of the inferior pubic
ramus at a 45˚ angle off the midline creating a pathway for
delivery device placement. (See Figure 2).
Dissection
Pathway
Figure 2: Dissection Pathway
Sling Placement
4. Place the mesh assembly onto the delivery device by placing
the delivery device tip into the mesh carrier (See Figure 3).
Note: The mesh carrier should be pushed onto the delivery
device tip until it is flush with the end of the delivery device
shoulder (See Figure 3). While placing the mesh carrier onto
the delivery device, make sure that the mesh is oriented so
that it lies on the outside curve of the delivery device (See
Figure 4). The mesh is now ready for placement.
Dual manufactured product; no change in content as of January 22, 2018.
For current version refer to the DFU packaged with the product.
12Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

7
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
PRECAUTION
Hold each side of the mesh carrier (See Figure 3) to avoid
possible glove puncture.
Flush With Delivery
Device Shoulder
Figure 3: Mesh Assembly Placement onto Delivery Device
Outside Curve
Of Delivery Device
Figure 4: Mesh Orientation on Delivery Device
5. Insert the delivery device into the dissection pathway
targeting placement of the carrier at a 45˚ angle off the
midline. (See Figure 5) Advance the delivery device towards
the obturator foramen just lateral to the inferior pubic
ramus (See Figure 5) until the midline mark on the delivery
device is approximately at the midline position under the
urethra. Deposit the carrier by gripping the deployment
mechanism with one hand and pulling the delivery device
handle back with the other hand (See Figure 6). This action
will deposit the carrier into surrounding muscle tissue
releasing it from the delivery device.
NOTE: Once the carrier is deposited in tissue, it is not
designed to be reconnected onto the shaft tip for additional
tension/adjustment.
WARNING
If excessive resistance is encountered during advancement/
withdrawal, stop and determine remedial action prior to proceeding.
8
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
Figure 5.
Figure 6.
Figure 7
6. Remove the delivery device from the incision. Bring the
deployment mechanism back to start position, flush with
the handle (See Figure 7).
NOTE: Once the carrier is deposited in tissue, it is not
designed to be reconnected onto the shaft tip for additional
tension/adjustment.
7. Place the second mesh carrier onto the delivery device
following instructions from Step 4. Make sure that the mesh
is not twisted so that it will lie flat under the urethra when
placement is complete.
Dual manufactured product; no change in content as of January 22, 2018.
For current version refer to the DFU packaged with the product.
13Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

Dual manufactured product; no change in content as of January 22, 2018.
For current version refer to the DFU packaged with the product.
66
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
Catalog Number
Número de catálogo
Numéro de catalogue
Bestell-Nr.
Numero di catalogo
Catalogusnummer
Referência
Ref
Consult instructions for use.
Consultar las instrucciones de uso.
Consulter le mode d’emploi.
Gebrauchsanweisung beachten.
Consultare le istruzioni per l'uso.
Raadpleeg instructies voor gebruik.
Consulte as Instruções de Utilização
Contents
Contenido
Contenu
Inhalt
Contenuto
Inhoud
Conteúdo
EU Authorized Representative
Representante autorizado en la UE
Représentant agréé UE
Autorisierter Vertreter in der EU
Rappresentante autorizzato per l'UE
Erkend vertegenwoordiger in EU
Representante Autorizado na U.E.
EC REP
Legal Manufacturer
Fabricante legal
Fabricant légal
Berechtigter Hersteller
Fabbricante legale
Wettelijke fabrikant
Fabricante Legal
Lot
Lote
Lot
Charge
Lotto
Partij
Lote
LoT
Recyclable Package
Envase reciclable
Emballage recyclable
Wiederverwertbare Verpackung
Confezione riciclabile
Recyclebare verpakking
Embalagem Reciclável
Use By
Fecha de caducidad
Date limite d’utilisation
Verwendbar bis
Usare entro
Uiterste gebruiksdatum
Validade
Australian Sponsor Address
Dirección del patrocinador australiano
Adresse du promoteur australien
Adresse des australischen Sponsors
Indirizzo sponsor australiano
Adres Australische sponsor
Endereço do Patrocinador Australiano
AUS
For single use only. Do not reuse.
Para un solo uso. No reutilizar.
À usage unique. Ne pas réutiliser.
Für den einmaligen Gebrauch. Nicht
wieder verwenden.
Esclusivamente monouso. Non riutilizzare.
Uitsluitend bestemd voor eenmalig
gebruik. Niet opnieuw gebruiken.
Apenas para uma única utilização. Não
reutilize.
Argentina Local Contact
Contacto local en Argentina
Contact local en Argentine
Lokaler Kontakt Argentinien
Contatto locale per l'Argentina
Contactpersoon Argentinië
Contacto local na Argentina
ARG
9
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
8. Insert the delivery device into the dissection pathway on
the contralateral side targeting placement of the carrier
at a 45˚ angle off the midline (See Figure 8). Advance the
delivery device towards the obturator foramen just lateral
to the inferior pubic ramus (See Figure 8) until appropriate
mesh placement is achieved. Deposit the carrier by gripping
the deployment mechanism with one hand and pulling the
delivery device handle back with the other hand (See Figure 6).
This action will deposit the carrier into surrounding muscle
tissue, releasing it from the delivery device.
Figure 8: Contralateral Delivery Device Placement
9. Remove the delivery device from the incision.
10. Cystoscopy may be performed at this time, to be determined
at the physician’s discretion.
11. Close incisions according to usual methods.
WARRANTY
Boston Scientific Corporation (BSC) warrants that reasonable
care has been used in the design and manufacture of this
instrument. This warranty is in lieu of and excludes all other
warranties not expressly set forth herein, whether express
or implied by operation of law or otherwise, including, but
not limited to, any implied warranties of merchantability
or fitness for a particular purpose. Handling, storage,
cleaning and sterilization of this instrument as well as other
factors relating to the patient, diagnosis, treatment, surgical
procedures and other matters beyond BSC’s control directly
affect the instrument and the results obtained from its use.
BSC’s obligation under this warranty is limited to the repair
or replacement of this instrument and BSC shall not be liable
for any incidental or consequential loss, damage or expense
directly or indirectly arising from the use of this instrument. BSC
neither assumes, nor authorizes any other person to assume for
it, any other or additional liability or responsibility in connection
with this instrument. BSC assumes no liability with respect to
instruments reused, reprocessed or resterilized and makes
no warranties, express or implied, including but not limited
to merchantability or fitness for a particular purpose, with
respect to such instruments.
14Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

Dual manufactured product; no change in content as of January 22, 2018.
For current version refer to the DFU packaged with the product.
67
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
Do Not Resterilize
No reesterilizar
Ne pas restériliser
Nicht erneut sterilisieren
Non risterilizzare
Niet opnieuw steriliseren
Não reesterilize
sTERILIZE
2
Do not use if package is damaged.
No usar si el envase está dañado.
Ne pas utiliser si l’emballage est
endommagé.
Bei beschädigter Verpackung nicht
verwenden.
Non usare il prodotto se la confezione è
danneggiata.
Niet gebruiken als de verpakking is
beschadigd.
Não utilize se a embalagem estiver
danificada.
Sterilized using ethylene oxide.
Esterilizado por óxido de etileno.
Stérilisé à l’oxyde d’éthylène.
Mit Ethylenoxid sterilisiert.
Sterilizzato con ossido di etilene.
Gesteriliseerd met ethyleenoxide.
Esterilizado por óxido de etileno.
STERILE EO
Boston Scientific (Master Brand DFUTemplate 3in x 9in Global, 91031819AA), DFU, MB, Solyx, Global, 50431073-01A
Black (K) ∆E ≤5.0
© 2016 Boston Scientific Corporation or its affiliates.
All rights reserved.
Legal
Manufacturer
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
USA
USA Customer Service 888-272-1001
EU Authorized
Representative
Boston Scientific Limited
Ballybrit Business Park
Galway
IRELAND
EC REP
Recyclable
Package
Australian
Sponsor Address
Boston Scientific (Australia) Pty Ltd
PO Box 332
BOTANY
NSW 1455
Australia
Free Phone [phone]
Free Fax [phone]
AUS
Do not use if package
is damaged.
Argentina
Local Contact
ARG
Para obtener información de
contacto de Boston Scientific
Argentina SA, por favor, acceda al
link www.bostonscientific.com/arg
15Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

Lead Author Title Publication/Conference Year
Serels S, et al. Long term follow up of the Solyx Single-Incision Sling in the treatment of female
stress urinary incontinence (SUI) Open Journal of Urology 2014
Serels S, et al. Safety and ecacy of the Solyx Single-Incision Sling System for the treatment of
SUI: Preliminary results
UroToday International
Journal 2011
Serels S, et al. Preliminary ndings with the Solyx Single-Incision Sling System in female stress
urinary incontinence Int Urogynecol J. 2010
Clinical/Scientific Data
16Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

Is this product reimbursable by insurance?
The procedures for which it is used are reimbursable. Billing guides with respective coding and estimated Medicare
National Average reimbursement for sling operation for stress incontinence procedures are available online at
www.bostonscientic.com/reimbursement. For additional coding and reimbursement information, contact your
local Territory Manager or the Urology and Women’s Health Reimbursement Help Desk at [e-mail]
or 1-508-683-4022.
What is the Medicare Pass-Through Code (aka C-code or HCPCS)?
The Medicare Pass-Through Code for this product is C1771 (repair device, urinary, incontinence, with sling graft).
Is this a patient-chargeable product?
“Patient chargeable” is a colloquial term used to convey that a device/supply is appropriately charged to the
patient’s account (i.e. as a distinct line item on the patients claim) in the hospital/facility’s patient accounting or AR
system. It does not mean that the patient is actually charged directly for the device/supply nor would an insured
patient ever pay an additional amount “out of pocket” for the device/supply. The fact that a hospital/facility
chooses to designate certain devices/supplies (e.g. single-use devices) as “patient chargeable” will not in and of
itself result in immediate increased reimbursement for the hospital/facility. It will allow CMS to better factor the
true cost of the procedure into future Medicare reimbursement rate setting. It may also help in negotiations with
private payers by more clearly demonstrating novel device costs that have been introduced to a procedure.
The designation of a given device/supply as “patient chargeable” is entirely up to the discretion and policy of the
individual hospital/facility. Section 2202.8 of the Medicare Provider Reimbursement Manual dealing with Ancillary
Services (e.g. operating room) does not specically address which items are part of the basic (routine) charge and
which are charged in addition to the basic charge (non-routine). Medicare is on record that it is up to the individual
hospital to determine whether to and how to itemize the charge for a specic device/supply or alternatively
incorporate it into overhead (e.g. via the OR charge). However, Medicare does require that charges billed on the
CMS-1450 form (aka UB-04) be aggregated under the appropriate Revenue Code. The appropriate Revenue Code
is 272 – Medical/Surgical Supplies and Devices-Sterile Supply.
Reimbursement Guide
17Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

Relevant Reimbursement Codes:
Payer policies will vary and should be veried prior to treatment for limitations on diagnosis, coding or site of
service requirements. The coding options listed within this guide are commonly used codes and are not intended
to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options.
Procedure
Name
APC
Code CPT®Code ICD-10-PCS Procedure Codes
ICD-10-CM
Diagnosis Codes
Possible
MS-DRG Assignment1
Sling
Procedure
5415 57288 –
Sling operation
for stress
incontinence
(eg, fascia or
synthetic)
0TSC0ZZ – Reposition Bladder
Neck, Open Approach
0TSC4ZZ – Reposition Bladder
Neck, Percutaneous Endoscopic
Approach
0TUC07Z – Supplement Bladder
Neck with Autologous Tissue
Substitute, Open Approach
0TUC0KZ – Supplement Bladder
Neck with Nonautologous Tissue
Substitute, Open Approach
0TUC47Z – Supplement Bladder
Neck with Autologous Tissue
Substitute, Percutaneous
Endoscopic Approach
0TUC4KZ – Supplement Bladder
Neck with Nonautologous
Tissue Substitute, Percutaneous
Endoscopic Approach
0TUC77Z – Supplement Bladder
Neck with Autologous Tissue
Substitute, Via Natural or Articial
Opening
0TUC7KZ – Supplement Bladder
Neck with Nonautologous Tissue
Substitute, Via Natural or Articial
Opening
0TUC87Z – Supplement Bladder
Neck with Autologous Tissue
Substitute, Via Natural or Articial
Opening Endoscopic
0TUC8KZ – Supplement Bladder
Neck with Nonautologous Tissue
Substitute, Via Natural or Articial
Opening Endoscopic
0TQD0ZZ – Repair Urethra,
Open Approach
0TQD3ZZ – Repair Urethra,
Percutaneous Approach
0TQD4ZZ – Repair Urethra,
Percutaneous Endoscopic Approach
0TQD7ZZ – Repair Urethra,
Via Natural or Articial Opening
0TQD8ZZ – Repair Urethra, Via
Natural or Articial Opening
Endoscopic
0TQDXZZ – Repair Urethra,
External Approach
0TUC0JZ – Supplement Bladder
Neck with Synthetic Substitute,
Open Approach
0TUC4JZ – Supplement Bladder
Neck with Synthetic Substitute,
Percutaneous Endoscopic Approach
0TUC7JZ – Supplement Bladder
Neck with Synthetic Substitute,
Via Natural or Articial Opening
0TUC8JZ – Supplement Bladder
Neck with Synthetic Substitute,
Via Natural or Articial Opening
Endoscopic
N39.3 – Stress
incontinence
(female) (male)
N36.42 – intrinsic
Sphincter
Deciency (ISD)
N36.41 –
Hypermobility of
the urethra
748 – Uterine and
Adnexa Procedures for
Nonmalignancy with
CC/MCC1
662 – Minor bladder
procedures with
major complication or
comorbidity (MCC)
663 – Minor bladder
procedures with
complication or
comorbidity (CC)
664 – Minor bladder
procedures without
MCC/CC
CPT Copyright 2017 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to
Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their
use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Health economic and reimbursement information provided by Boston Scientic Corporation is gathered from third-party sources and is subject to change without notice as a result of complex
and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston
Scientic encourages providers to submit accurate and appropriate claims for services. It is always the provider’s responsibility to determine medical necessity, the proper site for delivery of
any services, and to submit appropriate codes, charges, and modiers for services that are rendered. It is also always the provider’s responsibility to understand and comply with Medicare
national coverage determinations (NCD), Medicare local coverage determinations (LCD) and any other coverage requirements established by relevant payers which can be updated frequently.
Boston Scientic recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage, and reimbursement matters. Payer policies will
vary and should be veried prior to treatment for limitations on diagnosis, coding or site of service requirements. The coding options listed within this guide are commonly used codes and are
not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options.
For additional coding and reimbursement questions please contact our Urology and Pelvic Health Reimbursement
Help Desk at [e-mail] OR 1-508-683-4022.
18Product Review for the Purchasing Committee
Solyx™Single-Incision Sling System

CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician trained in use
of surgical mesh for repair of stress urinary incontinence. Refer to package insert provided with this
product for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and
Instructions prior to using this product.
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www.bostonscientic.com
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or its aliates. All rights reserved.
WH-200803-AD MAY 2018