Saffron™ Fixation System
The Saffron™ Fixation System (Coloplast Corp., Minneapolis, MN) is a contemporary anchor-based device (ABD) for sacrospinous ligament (SSL) fixation in apical pelvic-organ-prolapse repair. Engineered to enable precise anchor placement in the SSL with the goal of reducing neurovascular injury risk, the system aims to facilitate a durable, fast, complication-minimizing apical-suspension procedure. Like the Anchorsure, it delivers a permanent biocompatible anchor into the ligament rather than capturing a suture across it.[1]
Design
- Two-piece system:
- Saffron tool — curved, ergonomic reusable handle; reprocessed between cases
- Saffron anchors — biocompatible, single-use, permanently implanted; sold in boxes of 12
- Narrow distal tip for clean entry into the dissection plane and accurate anchor placement
- Curved body matching the approach angle to the sacrospinous ligament
- Intuitive ergonomics for single-handed operation
Evidence — Cadaveric Validation Only
The Saffron has been validated in a single cadaveric observational study (van Raalte 2023, Int Urogynecol J). No clinical (in vivo) studies have been published.[1]
| Endpoint | Result |
|---|---|
| Anchor placement accuracy | 19/20 anchors (95%) correctly placed, by independent non-implanting-surgeon assessment |
| Neurovascular clearance | All anchors > 10 mm from surrounding nerves and vessels |
| Pull-out force (holding strength) | 17.9 ± 5.6 N mean |
| Study design | 4 human cadavers, 3 implanters; pull-out force in 3 cadavers, anatomic distance measurements in 1 |
The authors explicitly note that "future clinical studies are needed to explore if the theoretical advantages of this device translate to improved clinical outcomes in comparison with available suturing and anchoring devices."[1]
Positioning in the SSLF Landscape
The Saffron joins the Anchorsure as a contemporary anchor-based alternative to the dominant suture-capturing devices (Capio, i-Stitch, Endostitch) and the legacy suture-passers (Miya hook, Deschamps ligature carrier). The anchor-based concept addresses the same clinical pain point — characteristic gluteal / buttock pain after traditional SSLF — by embedding fixation within ligament substance rather than encircling or compressing it.
SSLF Device Landscape — Level of Evidence
| Device | Type | Manufacturer | Level of Evidence |
|---|---|---|---|
| Capio / Capio SLIM | Suture-capturing | Boston Scientific | Multiple clinical studies + systematic reviews |
| Anchorsure | Anchor-based | Neomedic | RCTs (Plair 2022)[2], case-control (Evangelopoulos 2024)[3], large retrospective series |
| Saffron | Anchor-based | Coloplast | Cadaveric study only (van Raalte 2023)[1] |
| EnPlace | Suture-passing | Neomedic | Clinical cohort studies (Neuman 2025)[4] |
| Deschamps ligature carrier | Suture-passing | Various | Extensive long-term clinical data |
The Amiri 2024 meta-analysis frames the broader pattern across SSLF devices: overall complication rates are low across all devices, but specific profiles diverge — suture-capturing devices tend to have higher nerve-injury rates, while anchor-based devices may have slightly higher reoperation rates.[5]
Clinical Status
The Saffron's promising preclinical metrics — 95% accuracy, > 10 mm neurovascular clearance, 17.9 N pull-out force — have not yet been validated in human clinical use. Until clinical data emerge, the Capio (suture-capturing, deepest evidence base) and Anchorsure (anchor-based, RCT + large retrospective series) remain the SSLF devices with the strongest evidence at the bedside.
Use
- Apical POP repair — vaginal vault suspension after hysterectomy
- Uterovaginal prolapse fixation
- Native-tissue (mesh-free) apical suspension
See also: Anchorsure System, Capio Suture Capturing Device, i-Stitch, Endostitch, Miya Hook, Deschamps Ligature Carrier.
References
1. van Raalte H, Bhatia N, Mangel J, Ryckebusch H, Roovers JP. "A novel anchoring system for pelvic organ prolapse repair: an observational study." Int Urogynecol J. 2023;34(7):1593–1598. doi:10.1007/s00192-022-05444-7
2. Plair A, Smith W, Hines K, et al. "Gluteal and posterior thigh pain from a suture compared with an anchor-based device in patients undergoing sacrospinous ligament fixation: a randomized controlled trial." Obstet Gynecol. 2022;139(1):97–106. doi:10.1097/AOG.0000000000004629
3. Evangelopoulos N, Delacroix C, Abdirahman S, de Tayrac R. "Safety of an anchor-based device for sacrospinous ligament fixation: a pilot case-control study." Eur J Obstet Gynecol Reprod Biol. 2024;299:105–109. doi:10.1016/j.ejogrb.2024.06.012
4. Neuman J, Groutz A, Neuman M, Gold RS. "Is transvaginal minimally invasive sacrospinous ligament fixation a safe and effective surgical approach for treating recurrent apical pelvic organ prolapse?" J Clin Med. 2025;14(15):5235. doi:10.3390/jcm14155235
5. Amiri E, Bastani P, Mallah F, Mostafaei H, Salehi-Pourmehr H. "Comparison of the complications rate of different suture-passing techniques at the time of sacrospinous ligament fixation: a systematic review and meta-analysis." Arch Gynecol Obstet. 2024;310(6):2791–2809. doi:10.1007/s00404-024-07788-5