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Utilizing the only mesh designed exclusively for the pelvic floor, Restorelle™ DirectFix A and P are the ideal surgical solutions for pelvic floor restoration where a minimally invasive direct fixation approach is preferred. Restorelle DirectFix™ is constructed with the most physiologically compatible material available, Smartmesh™ Technology, which delivers near-zero erosion rates, optimal tissue incorporation and collagen growth.
Benefits
- Ultra lightweight Smartmesh™ Technology offers:
- Lightest mesh in women’s health – 19 gsm1
- Less than 1% erosion rate in vaginal mesh repair1
- Near zero erosion rate
- High cure rates2,3
- 71% more mature type 1 collagen than heavier meshes4
- Non-palpable to patient and her partner5,6
- Vaginal elasticity maintained
- Novel fixation method:
- Slim single-use tacking device
- Address all classes of defects and provides strong apical support
- Pre-cut shapes made to best anatomically suit the patient
- Simple and less invasive
- Easy and fast procedure performed with high safety profile
- Less trauma to the sacrospinous ligament
Indications for Use
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Pelvic Floor Restoration:
- Restorelle™ DirectFix A - Anterior (mild, moderate, and severe)
- Restorelle™ DirectFix P - Posterior (mild, moderate, and severe)
Surgical Procedure
The target compartment is defined and dissection is performed out to the sacrospinous ligament or arcus tendineus. Apical fixation is undertaken with sutures. Sacrospinous fixation is achieved by using a narrow tacker device to deploy the helical fastener with the mesh attached and directly into the sacrospinous ligament bilaterally.
Ordering Information
¹Data on file. 2Alinsod, R. (2008) Long term outcomes of vaginal pelvic floor repair using an ultra lightweight mesh. Manuscript submitted for publication. 3Hawthorn, R et al. (2007). Use of an ultra lightweight mesh in vaginal vault repair to minimise complication: A two-centre observation study. British International Congress of Obstetrics & Gynaecology. 4Greca, FH et al. (2007). The influence of porosity on integration histology of two polypropylene meshes for the treatment of abdominal wall defects in dogs. Hernia, (12):45-49. 5North, C et al. A preliminary study to compare the vaginal palpability of two different mesh materials used for laparoscopic sacrocolpopexy. International Urogynecology Journal. 6North, C et al. The anatomical and functional outcome of laparoscopic sacrocolpopexy using an ultra lighweight polypropylene mesh (Mini-mesh). International Urogynecology Journal. |
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