SINGLE INCISION APICAL REPAIR
SPLENTIS is a single incision repair system, indicated for transvaginal bilateral sacrospinous cervicopexy of the apical pelvic organ prolapse in non-fertile women1. The sling alike implant is fixated bilaterally to the sacrospinous ligaments and centrally to the anterior supravaginal portion of the cervix. This implant configuration uses the minimal amount of alloplastic material, does not interfere with the anterior vaginal wall and demonstrates therefore excellent treatment success while minimizing adverse events2,3.
ADVANTAGOUS ANATOMICAL RESULTS
Splentis provides uterine suspension in a physiologic, central position by bridging the distance between the cervix and the sacrospinous ligaments through bilateral fixation. The apical fixation provides an excellent outcome without adversely affecting the anterior vaginal wall (3). Splentis is designed for uterine preservation and additionally, may be utilized after subtotal hysterectomy.
EFFECTIVENESS AND SAFETY OF APICAL POP REPAIR VIA TRANSVAGINAL ROUTE
A total of 113 non-fertile women with an average age of 68 years who underwent transvaginal POP repair with Splentis for mainly primary POP (94 %) were enrolled in a monocentric cohort trial with an average follow-up time of 17 months.
- The average time of surgery was 22 minutes
- In 99,1 % the treatment was successful, defined by POP-Q ≤ 1
- The exposure rates were very low with 2.7 %
In conclusion, Splentis can be considered effective and safe in non-fertile women with apical POP3.
- Splentis Instructions for Use 2021.
- Naumann, G. et. al.: Positive effects of vaginal bilateral hysteropexy with Splentis-tape on prolapse symptoms and quality of life in women with severe pelvic organ prolapse (2018).
- Naumann, G., Börner, C., Naumann, LJ. et al. A novel bilateral anterior sacrospinous hysteropexy technique for apical pelvic organ prolapse repair via the vaginal route: a cohort study. Arch Gynecol Obstet (2022). https://doi.org/10.1007/s00404-022-06486-4
SPLENTIS REINFORCING IMPLANT
Splentis is composed of biocompatible, lightweight, type 1 (macroporous, monofilamentous) polypropylene. The sling alike configuration of Splentis uses the lowest amount of alloplastic material to achieve a reliable physiological apical suspension in a central position.
TISSUE ANCHORING SYSTEM TAS
The TAS was developed to provide a reliable fixation to the sacrospinous ligament (SSL). It is composed of a polypropylene anchor with an attached polypropylene suture. The TAS serves to provide:
- Highest pull-out force and accuracy
- Reliable fixation
- Safety with regard to vascular and neural structures
- Six circumfemtially arranged spikes to provide a reliable fixation
- Safety Stop to prevent injuries of vascular and neural structures behind the ligament
RETRACTABLE INSERTION GUIDE – RIG
The Retractable Insertion Guide was developed to reach the targeted area for performing an accurate and safe anchor insertion. The configuration of the RIG, with its protective tube, guarantees the integrity of surrounding tissue during the implantation of the TAS into the sacrospinous ligament. With its ergonomic design, small diameter and retractable mechanism for connecting and releasing the anchors, the RIG provides:
- Precision and safety in surgical maneuvers
- Reduction of surgical dissection to a minimum
- Total control of connection and release of TAS anchors
Splentis must not be used in:
- Fertile women
- Women with post-(total) hysterectomy vaginal vault prolapse
- Patients with any active or latent infection of the vagina, cervix or uterus
- Patients with previous or current vaginal, cervical or uterine cancer
- Previous, current or planned pelvic radiation therapy
- Known allergy to polypropylene
The implantation of Splentis should be based on a thorough patient assessment along with the patient’s individual characteristics and preferences. The following items must also be considered:
- Splentis must ONLY be used by surgeons experienced in transvaginal pelvic floor reconstruction
- The surgical technique brochure must be read and understood PRIOR to the first implantation of Splentis
For further precautions and warnings, we refer to our Instruction for Use.