i-Stitch®
The i-Stitch® (A.M.I. — Agency for Medical Innovations, Austria) is a reusable suture-capturing device for sacrospinous ligament fixation (SSLF) in transvaginal apical-prolapse repair. Its distinguishing design feature is a blunt, ball-tipped suture advanced by a needle-slider mechanism through the ligament, navigated by finger guidance along the surgeon's digit to the medial posterior sacrospinous ligament. Cadaveric comparative data have flagged a vascular-safety concern specific to the i-Stitch's deeper tissue penetration; a contemporary innovation pairs the device with chip-on-tip endoscopic visual guidance to mitigate that concern.[1][2][3]
Design
- Reusable metal instrument with a loading unit
- Needle slider with integrated suture clamp
- Blunt, ball-shaped suture tip — pushed through tissue without a sharp needle cut
- Curved working end matching the sacrospinous-ligament approach angle
- Paired with BSC Mesh (A.M.I. bilateral sacrospinous colpopexy mesh) in the manufacturer's apical suspension protocol
Technique
- Secure the suture in the suture clamp of the i-Stitch loading unit
- Load the i-Stitch with the loading unit
- Guide the tip along the surgeon's finger to the intended sacrospinous-ligament attachment point
- Push the ball tip into tissue
- Push the loading unit forward — the suture penetrates the ligament via the ball tip
- Retrieve the suture on the opposite side
Vascular Safety Concern — Manning 2014 Cadaveric Comparative Study
The critical contemporary caveat. Manning and Arnold (2014) compared six sacrospinous suture devices in cadaveric specimens:[3]
- The i-Stitch was the only device observed to penetrate coccygeal branches of the inferior gluteal artery.
- The Capio, Caspari, and Endostitch remained confined within the ligament even in thin specimens.
- The authors concluded the i-Stitch "was not safe in thin ligaments" — particularly relevant in elderly patients, who have thinner sacrospinous ligaments and tolerate hemorrhage less well.
The Manning framework for the ideal SSLF device: compact, impressing and enfolding tissue without penetrating behind the ligament, with the sharp suture-carrying component traversing the shortest distance at the shallowest depth. The Caspari and Capio best satisfied these criteria; the i-Stitch did not.[3]
Novel Application — Visual Guidance with Endoscopy
The i-Stitch has been repurposed by Chene and colleagues in a chip-on-tip endoscopic guidance technique that directly addresses the blind-palpation failure mode behind the Manning vascular-safety signal. The combined system pairs the i-Stitch with a 1.9 mm NanoNeedle™ / NanoScope™ (Arthrex) to perform sacrospinous fixation under real-time visual guidance — the first practical operative-vision modification of any blind suture-passing SSLF technique.[1][2]
| Study | Design | Key Result |
|---|---|---|
| Chene 2024 anatomical | 3 female cadavers, bilateral SSLF with i-Stitch + NanoScope | Ischial spine and SSL always identifiable bilaterally; authors concluded the technique could improve safety and suture-placement accuracy[2] |
| Chene 2025 pilot clinical | 15 patients, apical prolapse, anterior and/or posterior SSLF with i-Stitch + NanoScope | No perioperative or postoperative complications; no postoperative pain; complete prolapse correction in 87% at 12 mo; significant satisfaction improvement on PGI / SF-12 / PFIQ-7 / PFDI-20 / PISQ-12 at 1, 6, 12 mo[1] |
The authors conclude that this minimally invasive visual-guidance approach could offer safety and placement-accuracy advantages over blind palpation-only SSLF. Clinical evidence remains very limited (single pilot study, n = 15); larger comparative studies are needed.[1]
Reconstructive / Urogyn Uses
- Bilateral sacrospinous ligament fixation (SSLF) — typically paired with the BSC Mesh
- Apical vaginal vault suspension (post-hysterectomy vault prolapse)
- Uterovaginal prolapse repair
- Anterior and posterior SSLF in the visual-guidance protocol (Chene 2024 / 2025)
SSLF Device Landscape — Safety Profile Comparison
| Device | Type | Key Manning 2014 / contemporary safety finding | Visual guidance |
|---|---|---|---|
| i-Stitch | Suture-capturing | Penetrated vessels in thin ligaments (only device to do so) | Yes — when paired with NanoScope (Chene 2024/2025) |
| Capio | Suture-capturing | Remained within ligament; pooled nerve-injury rate 3.8% (Amiri 2024)[4] | No |
| Caspari | Suture-capturing | Remained within ligament; best vascular safety profile | No |
| Endostitch | Suture-capturing | Remained within ligament | No |
| Anchorsure | Anchor-based | Tacker dislodgement 2.2% (Lo 2025)[5] | No |
| Deschamps ligature carrier | Suture-passing | Impinged but deflected vessels | No |
Bottom Line
The i-Stitch has a mixed safety profile:
- Cadaveric data raise vascular-penetration concern in thin ligaments (Manning 2014).[3]
- Recent pairing with endoscopic visual guidance is a potentially important innovation that may mitigate these risks by allowing direct visualization during suture placement (Chene 2024 / 2025).[1][2]
- Clinical evidence remains very limited — a single 15-patient pilot study for the visual-guidance combination; larger comparative trials are required before the safety advantage translates into a clinical recommendation.
The blind-palpation i-Stitch should be deployed with awareness of the Manning vascular-safety signal — particularly in elderly patients with thin ligaments, where the Capio / Caspari / Endostitch profile is theoretically safer. The NanoScope-guided variant is the device's most credible contemporary direction.
See also: Capio Suture Capturing Device, Endostitch, Anchorsure System, Saffron Fixation System, Deschamps Ligature Carrier, Miya Hook.
References
1. Chene G, Cerruto E, Moret S, Nohuz E. "The vaginal minimally invasive sacrospinous fixation under visual guidance: a pilot study." Eur J Obstet Gynecol Reprod Biol. 2025;317:114866. doi:10.1016/j.ejogrb.2025.114866
2. Chene G, Cerruto E, Moret S, Nohuz E. "The minimally invasive sacrospinous fixation under visual guidance: an anatomical study." Eur J Obstet Gynecol Reprod Biol. 2024;297:36–39. doi:10.1016/j.ejogrb.2024.03.039
3. Manning JA, Arnold P. "A review of six sacrospinous suture devices." Aust N Z J Obstet Gynaecol. 2014;54(6):558–63. doi:10.1111/ajo.12272
4. 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
5. Lo TS, Rellora LE, Yu CC, Ro AL, Yang CH. "Operator and patient injuries from tacker dislodgement during sacrospinous ligament fixation: a retrospective study." BJOG. 2025. doi:10.1111/1471-0528.70089