TREATMENT FOR RECURRENT & COMPLEX ANTERIOR PELVIC ORGAN PROLAPSE
Calistar S is intended for the transvaginal reestablishment and reinforcement of the physiological anatomy of the pelvic floor. It is intended for non-fertile women with recurrent or complex primary anterior pelvic organ prolapse (POP) with or without involvement of the apical vaginal wall1.
EFFECTIVENESS AND SAFETY OF ANTERIOR POP REPAIR VIA TRANSVAGINAL ROUTE
A total of 107 non-fertile women who underwent transvaginal POP repair with Calistar S for either recurrent (87%) or complex (13%) anterior POP with a mean follow-up of 19 months were enrolled in a multicenter cohort trial:
- The average time for Calistar S implantation was only 38 Minutes
- In 98% the Treatment was successful, defined by POP-Q ≤ 1
- The Exposure rates were very low with 5.6%
In conclusion, Calistar S can be considered effective and safe in women with recurrent or complex anterior POP2.
- Calistar S Instructions for Use 2020.
- Naumann, G., Hüsch, T., Mörgeli, C. et al. Mesh-augmented transvaginal repair of recurrent or complex anterior pelvic organ prolapse in accordance with the SCENIHR opinion. Int Urogynecol J 32, 819–827 (2021). https://doi.org/10.1007/s00192-020-04525-9
The Calistar S implant is composed of biocompatible type 1 macroporous, monofilamentous polypropylene with two anterior attachment arms and two posterior mesh arms. The reliable four-point fixation resists a pull-out force exceeding up to four times the maximum abdominal pressure.
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 Guides were developed to reach the targeted areas for performing an accurate and safe anchor insertion. Its curved design facilitates the introduction and placement of the anchor in the correct angle. With their ergonomic design, small diameter and retractable mechanism for connecting and releasing the anchors, both RIGs provide:
- Precision and safety in surgical maneuvers
- Reduction of surgical dissection to a minimum
- Total control of connection and release of anchors
The small RIG was developed to place the anterior attachment arms of the implant into the internal obturator muscle.
The configuration of the large RIG guarantees the integrity of surrounding tissue during the implantation of the TAS into the sacrospinous ligament.
ANTERIOR ANCHOR RIG
Calistar S must not Be used in:
- Fertile women
- 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 Calistar S should be based on a thorough patient assessment along with the patient’s individual characteristics and preferences. The following items must also be considered:
- Calistar S 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 Calistar S.
For further precautions and warnings, we refer to our Instruction for Use.