Warning; Device Description; Intended Use/Indications For Use; Contraindications - Boston Scientific Solyx Mode D'emploi

Solyx
SIS System
Solyx Blue
SIS System
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.
™
3
Black (K) ∆E ≤5.0