Description

The X-Tense^® Frechet Extender is composed of a new generation silicone elastomeric sheet with two rows of titanium hooks on each side.

The device generates an extension of physical and biological tissues outside the hooks. Tissue located inside the hooks will contract.

The duration of implantation: 25 to 29 days max.

How to use the X-Tense^®?

The X-Tense^® Frechet Extender is sold in a sterile ready to use pack.
The device is available in 2 different sizes: each model is designed for a specific rate of extension:

Choice of model:

Width of defective skin	Model number	A range of extension - 100% extension
6 to 10 cm	F130	15 cm
10 to 16 cm	F140	19 cm

For maximum results in minimal time, you can implement two X-Tense^® one behind the other. In this case, limit the extension to 100% for each X-Tense^®.

Number of extensions necessary:

• For up to 10 cm width of defective skin before surgery: 1 or 2 extensions are necessary.

• For 10 - 15 cm width of defective skin before surgery: 2 extensions are necessary.

• For 16- 18 cm width of defective skin before surgery: 3 extensions are necessary.

Possible side effects:

• Pain: it is perfectly tolerable with conventional pain killers. The level of pain depends on the level of extension, and at a moderate extension to 100%.

• Frontal temporarily swelling can be observed in approximately 15% of cases.

How to use the X-Tense^®

First time Implantation of X-Tense^®

1/ With a pencil, draw a 2 in. (5cm) line on the skin that is 0 in. to 0.4 in. (0cm to 1cm) inside the healthy skin margin.

2/ Draw a similar line on the opposite area.

3/ Select the appropriate X-Tense^®. Refer to the following section: Select a suitable X-Tense^®.

4/ To maintain sterility, change gloves at this stage before handling the X-Tense^®.

5/ Using a needle holder, grasp one of the titanium strips as shown in fig 2. (cf.Figure 2).

6/ Using a needle holder, place the titanium strip under the skin and tine up the row of hooks with the line you drew in step 1.

7/ Insert the strips in the galea.

You are now ready to insert the second row of hooks on the opposite side.

8/ Use the Sterlab Hook Guide as shown in fig 4. Pushing the second titanium strip to the level of the second line drawn on the skin.
As the first strip is already in place, you will notice some tension when stretching the X-Tense^®.

9/ Check that all hooks are properly inserted under the skin. If any hook is not inserted, grasp the end of the strip with your needle holder and bend the trip so that the hook penetrates under the skin.

10/ Suture the wound edges while taking care not to damage the silicone
elastomer sheet.

Note: the X-Tense^® is now implanted and should be left in place for 25 to 29 days (maximum).

Removal of the X-Tense^®

1/ Take off the tissues under the X-Tense^® as deep as possible. Use a scalpel if some tissues are stuck on the hook raws.

2/ Using a needle holder, grasp one of the titanium strips and make it twist in order to disengage the hooks from the galea, as shown in fig.5.

3/ Follow the same procedure to disengage the second row of hooks.

4/ Remove the X-Tense^® which must be treated as contaminated medical waste.

5/ Suture.

Additional Implantations of the X-Tense^®

You may consider implanting a new X-Tense^® if more than 1.2 in.(3 cm) width of defective skin remains. Follow the procedure described in « First-time Implantation of an X-Tense^® » taking into account the following changes:
- smaller X-Tense^®
- Fix the hooks 0.4 in. to 0.75 in. (1 cm to 2 cm) inside each healthy skin area.

Documentation .pdf