Dr. Baccichet Corso GLUP TV - 22-23 marzo 2013

1. Uroginecologycal department
Chef: Dott. Roberto Baccichet
REGIONE VENETO
AZIENDA UNITA’ LOCALE N 9
OSPEDALE “Cà Foncello” TREVISO
DIPARTIMENTO MATERNO-INFANTILE
STRUTTURA COMPLESSA DI GINECOLOGIA E OSTETRICIA
Dir. Dr. G. Dal Pozzo

3. Distal Instrumentation
1. AJUST® Introducer
2. Stylet (23cm) – Longer than AJUST® stylet by 5cm

4. Obturator foramen

5. Proximal Instrumentation
1. Tube Mesh Introducer (FIXT™)
2. Deployment Tool (x3)
• Lockout mechanism
• Why 3?
3. Securement ring (pre-loaded)

6. Device Comparison
Bite depth
– Designed to approach and
deliver suture to the front 1/3
of the sacrospinous ligament
7.7mm 9.7mm

7. Device Comparison
FIXT™ Suturing Device Capio® Suture Capturing Device

8. Device Comparison
FIXT™ Suturing Device Capio® Suture Capture Device
Shaft width* 4.8mm 10.8mm
Predominant
Stainless Steel Plastic
material
Actuation In line trigger Plunger
Bite Depth* 7.7mm 9.7mm
Rate of Misfire* 2% 13%
* Data on file

9. General Implant Materials
• Type I Macroporous Polypropylene
Mesh
• Variable knit technology with dual
density sections
• Center section – 23.3g/m2 (AVAULTA® = 33.7g/m2)
• Side panels – 58.1g/m2 (AVAULTA® = 64.5g/m2)
• Large Pore center section
• Pore size – 3.4mm x 4.2mm
• Stainless steel proximal arm needle
points
• Polypropylene anchors and
securement rings

10. Mesh Implants
Density: 23 g/m²
Posterior
Anterior

11. Apical/Anterior Implant
7.5cm
9cm
4.5cm
4.5cm
SSL to SSL ~ 12cm

12. Apical/Posterior Implant
8cm
13.5cm
9.5cm
4.5cm

13. Pre-clinical Data
(Tubular mesh – 28 days)
Goat sacrotuburous model
Pinnacle™ flatmesh
AVAULTA® flatmesh
NUVIA™ SI tubular mesh
* Securement ring
# Sacrotuberous ligament
+ Skeletal muscle
• Histology did not indicate necrosis in any of the groups.
• Minor calcification found around Pinnacle and AVAULTA®, but not in NUVIA™ SI.
• No significant difference in the inflammatory response amongst the three
groups.

14. Pre-clinical Data
(Sewn joint – 28 days)
• Histology: Goat gracilis muscle
• materials showed a mild and typical inflammatory
response
• Expected in-growth occurring

15. Proximal arms placement
Connect the tip of the proximal arm to the Fixt
introducer

16. Proximal arms placement
Position the introducer at the level of the sacrospinous ligament approximately 2cm
medial to the ischial spine

17. Proximal arms placement
Fully actuate the introducer to deliver the tubular arm through the ligament
Use firm, downward pressure while actuating the device
When actuating the handle don’t pull nor maintain the mesh

18. Proximal arms placement
Draw the tubular mesh arm through the
ligament by withdrawing the introducer
from the vaginal dissection.
Use your index finger to maintain the
sacrospinous ligament.
Adjust the graft tension by pulling with
vibratory movements on the mesh arms.

19. Proximal arms placement
Release the tip of the mesh arm from the introducer by depressing the button on the
underside of the Fixt device.

20. Proximal arms placement
This action begins to draw the graft
into the repair site.

21. Distal arms placement
Place the anchor into the introducer and secure by retracting the release lever on the handle
A slight “click” should be felt or heard to confirm secure loading

22. Distal arms placement
Insert the introducer into the vaginal dissection laterally through the dissected plane toward
the cephalad aspect of the ischiopubic ramus.

23. Distal arms placement
Once anchor placement is appropriate, release it by pushing the release lever forward.
Gently remove the introducer through the insertion path.

24. Mesh Positioning and Securement
Position the implant by gently pulling on the adjusting tabs
Insert a finger vaginally to stabilize the anchor at the obturator internus muscle.
If required, the mesh can be loosened by using a gentle counter-traction on the implant
body at the connection with the tube arm. Use the midline indicator to ensure correct
left-to-right positioning.

25. Mesh Positioning and Securement
“Additional sutures should be used apically and may be used distally to secure the mesh
tension-free.
Anchoring points should be positioned at least 1 cm from the edge of the mesh.

26. Mesh Positioning and Securement
Secure the distal arms in position by inserting the flexible stylet into the adjusting tabs.
Slide it up the tubular mesh.
Mesh lock is in the proper location when the flexible stylet bows
Repeat the same step on the contralateral side using the same stylet
Remove the flexible stylet.

27. Mesh Positioning and Securement
Use Metzenbaum scissors to trim the excess distal tubular mesh.

28. Mesh Positioning and Securement
Slide down to the level of the sacrospinous ligament

29. Mesh Positioning and Securement
Ensure the mesh is positioned in a tension-free manner.
Fully depress the white button to release the securement ring and to trim the excess mesh arm
Don’t pull the mesh arm while depressing the button.

30. Mesh Positioning and Securement