i-Stitch®
The i-Stitch® (Agency for Medical Innovations, A.M.I., Austria) is a reusable instrument with a single-use suture loading unit for pelvic-floor suspension sutures, including sacrospinous ligament fixation (SSLF). The manufacturer's loading unit uses a needle slider and specially formed blunt, ball-shaped suture tip; the surgeon guides the instrument along a finger to the selected attachment point. In a cadaveric comparison of six sacrospinous suture devices, the i-Stitch was the only device that penetrated vessels behind the ligament; a 15-patient pilot has paired it with endoscopic visual guidance.[1][2][3][6]
Design
- Reusable instrument, supplied with cleaning accessories, plus single-use loading unit; follow current model-specific processing instructions.
- Needle slider with integrated suture clamp, separate cannulated needle, suture dispenser and blunt ball-shaped suture tip.[6][7] The loading unit contains a needle.[6][7]
- i-Stitch has a caudally directed tip for Level I/II placement; i-Stitch up has a cranially directed tip for Level III. Manufacturer-listed loading units offer absorbable and nonabsorbable suture options.[6]
- Can be used for native-tissue repair or mesh placement. A.M.I. also describes pairing it with its BSC Mesh and InGYNious systems.[6]
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 so the suture penetrates the intended tissue.
- Release the suture from the clamp and remove the loading unit; carefully retrieve the instrument while leaving the suture in place.[6]
Vascular Safety Concern — Manning 2014 Cadaveric Comparative Study
Manning and Arnold (2014) compared six sacrospinous suture devices in five preserved pelves/hemipelves with vessels attached. These are anatomy or simulation findings, not clinical injury rates:[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 judged the i-Stitch not safe in thin ligaments, described the vascular anatomy behind the ligament as highly variable, and noted that the ligament may be thin in elderly patients, who tolerate hemorrhage poorly.
The authors favored a compact device taking a shallow bite without penetrating behind the ligament; Capio and Caspari best satisfied their cadaveric criterion. Even a location two fingerbreadths medial to the ischial spine did not guarantee avoidance of vessels.[3]
Novel Application — Visual Guidance with Endoscopy
Chene and colleagues described combining i-Stitch with a 1.9 mm NanoNeedle™ / NanoScope™ (Arthrex) for endoscopic landmark visualization during sacrospinous fixation. The ischial spine and sacrospinous ligament were identified in every cadaver and patient in these reports.[1][2]
| Study | Design | Key Result |
|---|---|---|
| Chene 2024 anatomical | 3 female cadavers, bilateral fixation with visual guidance | Ischial spine and SSL could be identified[2] |
| Chene 2025 online / 2026 issue pilot | 15 patients with apical prolapse, guided anterior or posterior fixation | No complications or postoperative pain reported; 87% complete correction at 12 months in a small uncontrolled series; rare harms and comparative benefit remain unknown[1] |
The15-person uncontrolled series did not compare i-Stitch with palpation-guided SSLF or quantify vascular-risk reduction.[1]
Reconstructive / Urogyn Uses
- Bilateral sacrospinous ligament fixation (SSLF). Native-tissue or selected mesh-assisted approach; manufacturer describes BSC Mesh as one optional pairing
- Apical vaginal vault suspension (post-hysterectomy vault prolapse)
- Uterovaginal prolapse repair
- Anterior and posterior SSLF in the visual-guidance pilot (Chene, online 2025)
SSLF Device Landscape — Safety Profile Comparison
| Device | Type | Key Manning 2014 / contemporary safety finding | Visual guidance |
|---|---|---|---|
| i-Stitch | Suture-placement instrument | Penetrated coccygeal vessels in Manning's preserved specimens | Described with NanoScope in one feasibility pilot |
| Capio | Suture-capturing | Remained within ligament in Manning's specimens; Amiri's meta-analysis reported 3.8% nerve injury across techniques, highest with Capio[3][4] | Not compared in Chene pilot |
| Caspari | Suture-capturing | Remained within ligament in Manning's specimens | Not compared |
| Endostitch | Suture-capturing | Remained within ligament in Manning's specimens | Not compared |
| Anchorsure | Anchor-based | Lo's 676 cases used several tacker systems, only 19 Anchorsure alone; no Anchorsure-specific dislodgement rate[5] | Not compared |
| Deschamps ligature carrier | Suture-passing | Impinged but deflected vessels in Manning's specimens | Not compared |
Bottom Line
The i-Stitch has a mixed safety profile:
- Cadaveric data raise vascular-penetration concern in thin ligaments (Manning 2014).[3]
- Pairing with endoscopic visual guidance demonstrates feasibility of landmark visualization but has not been shown to prevent vascular injury (Chene 2024 and online 2025).[1][2]
- Clinical evidence is limited to one uncontrolled 15-patient pilot of the visual-guidance combination, with no comparison against palpation-guided SSLF.[1]
When selecting a device, account for patient-specific ligament and vascular anatomy and the Manning cadaveric warning. Neither that anatomical comparison nor the visual-guidance pilot establishes a clinically safer instrument or preferred approach.
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. 2026;317:114866 (online 2025). 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. 2026;133(4):716–724 (online 2025). doi:10.1111/1471-0528.70089
6. A.M.I. i-Stitch product description and loading-unit instructions. Accessed 2026-09-21.
7. A.M.I. Solutions for Urogynecology: Order Information. Undated, p. 32. PDF.