Product

Vaginal Tactile Imager (VTI)


Principle of Operation

The VTI allows acquisition of the pressure response patterns during tissue/structure deformations from vaginal walls along the entire vagina to visualize vaginal and pelvic floor support structures, and to record pelvic floor muscle contraction patterns. The VTI software provides data visualization, analysis, information and reporting tools. The acquired data can then be used for quantitative biomechanical assessment of the vaginal and pelvic floor conditions.

Indications for Use (FDA)

"The Vaginal Tactile Imager obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel."

CPT Code (AMA)

The VTI examination procedure has the dedicated Category III CPT code 0487T "Biomechanical mapping, tranvaginal, with report".

Clinical Utility

The female pelvic structures have varying viscoelastic characteristics across physiological states, healthy and diseased conditions. The VTI provides a large body of measurements to evaluate individual variations in support defects as well as identify specific potential markers to measure soft tissue properties and muscle function in patients with POP, SUI and tissue atrophy.

Recent study with 255 surgical procedures at 5 clinical sites demonstrated that biomechanical changes resulting from POP surgery can be predicted with the VTI.

The VTI may be used for:
- POP: to characterize its development in biomechanical terms
- SUI: to quantify pelvic muscle defects which contribute into SUI
- Atrophy: to characterize the vaginal tissue atrophy
- Surgery: to provide metrics of pelvic floor surgery outcome
- Physiotherapy: to monitor pelvic conditions in the course of applied treatment
- RF, Laser: to evaluate vaginal conditions before and after laser or RF treatment
- Military, Sport: to monitor pelvic floor changes under a heavy, repetitive load

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