CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

CONTRAINDICATIONS
   • Stratasis TF should not be used in patients with known sensitivity to
      porcine material.
   • The Stratasis TF procedure should not be performed on pregnant patients.

PRECAUTIONS
Material
   • Do not resterilize or reuse any portion of this device.
   • Device is sterile if the package is dry, unopened, and undamaged.
   • Do not use if the seal is broken.
   • Discard the device if mishandling and possible damage has
      occurred, or if the device is past its expiration date.
   • Device should be inspected. Defective product should be discarded
      or returned.
   • Ensure that Stratasis TF is rehydrated prior to placement.

General
   • Users should be familiar with surgical technique for pubourethral
      slings and bladder neck suspensions.
   • Users should exercise good surgical practice for the management of
      contaminated or infected wounds.
   • The potential for infection of a graft material following implantation
      may be reduced by the use of prophylactic antibiotics.
   • Users should exercise caution to avoid vessel, bowel, and bladder
      perforation.
   • Excess tension on Stratasis TF may result in urinary retention.
   • Cystoscopy should be performed to identify any bladder perforation
      and ensure bladder integrity.
   • Stratasis TF should not be used on patients who are on anti-
      coagulation therapy without appropriate medical consideration.
   • Users should counsel patient to contact them immediately should
      postoperative bleeding, dysuria, or other problems occur.
   • IMPORTANT: Users should counsel patients on abstaining from
      heavy lifting, strenuous exercise, and intercourse for a period of
      four (4) to six (6) weeks after sling placement.

POTENTIAL IMPLANT RESPONSES
As Stratasis TF becomes incorporated into the native tissue, signs of tissue remodeling are expected and may be evidenced for up to approximately six (6) weeks post-placement. Following placement, host tissue cells and blood vessels populate the sling to allow remodeling to occur. As a result, at the abdominal incision sites there may be localized redness, swelling, and/or pain. The site may feel firm and warm to the touch. This response is expected to resolve as the tissue remodeling phase is completed. Although post-operative infection is always a possibility with any procedure, this tissue remodeling response should not be presumed to be an infection.

POTENTIAL COMPLICATIONS
The following complications are possible with the use of surgical graft materials: bleeding, infection, adhesions, sterile effusion, chronic inflammation, allergic reaction, and delayed or failed incorporation of the device. Complications of any sling placement procedure include voiding dysfunction, bladder perforation, de novo urgency, erosion, persistent incontinence, urinary retention, and urinary fistula. If conditions of infection, inflammation or allergic reaction cannot be resolved, consider removal of the Stratasis TF Sling.

STORAGE / STERILIZATION
Stratasis TF should be stored in a clean, dry place at room temperature. This device has been sterilized with ethylene oxide prior to distribution and should not be resterilized.

SUGGESTED INSTRUCTIONS FOR USE
Preparatory

1. Using aseptic technique, remove Stratasis TF from its outer package and place the inner package into the sterile field.
2. Using aseptic technique, remove the suture carriers from their package and place into the sterile field.
3. Rehydrate Stratasis TF in sterile saline or sterile lactated Ringer’s solution for at least ten (10) minutes.
4. Prepare the surgical site using standard surgical techniques.

Procedural

1. Perform under local, regional, or general anesthesia.
2. Place a urethral catheter and drain the bladder.
3. Make two small (0.5 to 1.0 cm) abdominal skin incisions on each side of the midline just above the pubic symphysis.
4. Starting approximately 1 cm from the outer urethral meatus, make a midline vertical anterior vaginal incision of approximately 2 cm toward the bladder neck.
5. Create a small paraurethral space bilaterally by dissecting the vaginal wall from the urethra.
6. 6A. Antegrade Placement Technique
   1. Deflect the bladder and urethra to the contralateral side before insertion of the suture carriers to minimize the risk of bladder or urethral perforation.
   2. Pass the suture carrier through the suprapubic incision and along the posterior aspect of the pubic bone to minimize risk of vascular injury. Using a finger placed into the ipsilateral aspect of the vaginal incision, guide the suture carrier downward and through the vaginal incision.
   3. When the first suture carrier is in place, repeat the procedure (6A, steps 1 and 2) on the contralateral side.
   4. Perform cystoscopy to ensure that the bladder and urethra were not penetrated during the passage of the suture carriers.
   5. Pass the attached suture from Stratasis TF through the eyelet of the carrier and pull the suture back through the suture carrier tract externalizing it at the suprapubic site.
   6. Repeat on the contralateral side.
   
   6B. Retrograde Placement Technique
   1. Deflect the bladder and urethra to the contralateral side before insertion of the suture carriers to minimize the risk of bladder or urethral perforation.
   2. Pass the suture carrier through the paraurethral space, directing it slightly lateral and behind the inferior surface of the pubic symphysis. Using the posterior aspect of the pubic bone, to minimize risk of vascular injury, guide the suture carrier to the corresponding suprapubic incision.
   3. When the first suture carrier is in place, repeat the procedure (6B, steps 1 and 2) on the contralateral side.
   4. Perform cystoscopy to ensure that the bladder and urethra were not penetrated during the passage of the suture carriers.
   5. Remove the handle of the suture carrier (turn the locking mechanism in a counterclockwise direction) to expose the eyelet and pass the attached suture from Stratasis TF through the eyelet of the carrier and pull the suture through the suture carrier tract externalizing it at the suprapubic site.
   6. Repeat on the contralateral side.
7. Grasp the exposed sutures at the suprapubic site and center the midline of the sling under the urethra.
8. Adjust the sling to provide the appropriate amount of support to prevent incontinence while avoiding excess tension.
9. A second cystoscopy is advised to ensure that the bladder or urethra was not penetrated during sling placement.
10. When the Stratasis TF is properly positioned, trim the ends of the sling straight across through the abdominal incisions at the level of the rectus fascia.
    IMPORTANT: The sling should be transected at the level of the rectus fascia in order to minimize contact with tissues above the rectus fascia. Refer to Figure 1.
    

    

11. Close the suprapubic and vaginal incisions.
12. At the physician’s discretion, a urinary drain may be left in place until the patient is able to void.

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