Saffron™ Fixation System
The Saffron™ Fixation System (Coloplast) attaches suture to pelvic-floor ligaments using a permanently implanted polysulfone anchor. It received US FDA 510(k) clearance K220420 for that indication, with Anchorsure as the predicate. Clearance was based on nonclinical substantial-equivalence testing, not a comparative patient-outcomes trial. The device may be used for sacrospinous ligament fixation (SSLF) in apical prolapse repair.[1][6][7]
Design
- Two-piece system:
- Saffron tool. Sterile, single-use disposable delivery tool that may place multiple anchors in one patient's procedure; do not reprocess between cases
- Saffron anchors. Polysulfone, single-use, permanently implanted; sold separately 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
- Suture compatibility: most commercially available sutures up to size 0, excluding barbed sutures, per the current manufacturer page[6][7]
Evidence — Cadaveric Study and Regulatory Testing
The cited Saffron-specific outcome study (van Raalte 2023) is cadaveric. The FDA clearance summary describes bench, usability and cadaver work, and explicitly says no animal or clinical testing was submitted for substantial equivalence. Neither source shows better patient outcomes or clinical neurovascular safety than other devices.[1][7]
| Endpoint | Result |
|---|---|
| Anchor placement accuracy | 19/20 anchors (95%) correctly placed, by independent non-implanting-surgeon assessment |
| Neurovascular distance | >10 mm for measured nerves and vessels in one dissected cadaver |
| Pull-out force | 17.9 ± 5.6 N across 18 tested anchors in 3 other cadavers; manual pull rate not controlled |
| Study design | 4 previously frozen cadavers; 3 for placement/force and 1 for anatomical distances; no clinical follow-up |
The authors call for future clinical comparisons.[1]
Positioning in the SSLF Landscape
Saffron is an anchor-based alternative to suture-capturing devices (Capio, i-Stitch, Endostitch) and reusable carriers (Miya Hook, Deschamps). The fixation mechanism differs, but a reduction in buttock pain or other clinical complications has not been demonstrated for Saffron in the cited study.
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 | One RCT against a suture-capturing device (Plair 2022, 47 patients; no reduction in gluteal or thigh pain)[2]; pilot case-control (Evangelopoulos 2024)[3] |
| Saffron | Anchor-based | Coloplast | Cadaveric study and nonclinical 510(k) testing; clinical comparative outcome not established[1][7] |
| EnPlace | Anchor-based | FEMSelect | Clinical cohort studies (Neuman 2025)[4]; manufacturer IFU describes a tissue anchor[8] |
| Deschamps ligature carrier | Suture-passing | Various | Extensive long-term clinical data |
Amiri 2024 pools outcomes across different techniques; its abstract supplies a 3.8% overall nerve-injury rate and 1.2% overall reoperation rate, neither a Saffron-specific estimate nor proof of a device-class effect.[5]
Clinical Status
The 95% placement, >10 mm distance and 17.9 N force are cadaveric observations with different denominators. Select the device from the manufacturer instructions and the patient's anatomy, and counsel that clinical data for Saffron are limited.[1][6][7]
The manufacturer lists contraindications including pregnancy or plans for pregnancy, growth potential, polysulfone hypersensitivity, active infection, untreated or serious anticoagulant disorders, connective-tissue autoimmune disease and applications requiring placement of suture into or through bone. Listed risks include anchor migration, exposure or extrusion, bleeding, pain, dyspareunia and sexual dysfunction, storage and voiding symptoms, fistula, infection and adjacent organ, nerve or vessel injury.[6]
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
6. Coloplast. Saffron Fixation System: product details and brief safety statement. Accessed September 21, 2026. Full device-specific IFU not obtained.
7. US Food and Drug Administration. Saffron Fixation System, 510(k) K220420: clearance letter, indications and summary. June 10, 2022.
8. FEMSelect Ltd. EnPlace Instructions for Use. LB-0108 Rev. 1.0.