Vaginal Tactile Imager receives FDA approval

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Innovative Ob/Gyn imaging device receives FDA approval for marketing in the US

The rapid aging of the world’s population, driven by a reduction in fertility and mortality, implies additional requirements to the healthcare for the age related clinical conditions. The pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women are among them. These conditions affecting female pelvic floor interfere with daily life, normal functioning and accompanied by increased dependence on caregivers. POP is a highly prevalent condition affecting more 50% of women in the US during their lifetimes. The true etiology of POP and differences seen among individuals are not entirely understood. SUI is one of the most common urologic conditions, but it is poorly understood to apply effective treatments. An estimated up to 50% of elderly population have severe urinary incontinence.

The effective management of POP and/or SUI requires knowledge of the pathophysiologic mechanisms behind the disorder. Key to identifying these mechanisms and providing effective treatment to women is an understanding of the anatomy and function of the female pelvic floor and its support structures. It leads to correct diagnosis of the pelvic floor disorders, to optimal repair and deserving quality of life.

The new vaginal tactile imaging probe allows assessment of pelvic floor structures, functional imaging of the pelvic floor muscles and insight into the biomechanics to help understand the relative contribution of pelvic floor muscle in specific POP and/or SUI conditions by quantitative, anatomically sensitive and specific manner. Our findings demonstrate that high definition pressure mapping with the tactile imaging probe during voluntary and involuntary muscle contractions can be used for assessment of pelvic muscle conditions/defects which contribute into SUI; pressure mapping during Valsalva maneuver, pelvic floor muscle contractions and involuntary relaxation can be used for quantitative characterization of POP.

Pelvic floor muscle training and lifestyle changes are often a first line of therapy recommended to patients, especially for mild POP and SUI. The Vaginal Tactile Imager (VTI) will allow monitoring of pelvic floor specific changes in the course of applied therapy. The ability to evaluate the pelvic floor muscles relative strength in direct relationship to the soft tissue elasticity measurements through tactile imaging may help to better define candidates for conservative therapy or perioperative rehabilitation therapy. In addition, more accurate evaluation of the pelvic floor muscles may better define the impact of reconstructive pelvic surgery and individual patient needs surrounding surgical treatments.

The VTI allows 8 clinical tests for assessment of the female pelvic floor conditions.

The clinical studies demonstrate that:

  • The VTI examination procedure is safe.
  • The VTI examination is more comfortable than manual palpation.
  • The VTI allows tactile imaging of the vagina, pelvic floor support structures and pelvic floor muscle contraction.

FDA 510(k) Number: K142355
Approval Date: May 28, 2015
Device Name: Vaginal Tactile Imager (VTI)
Manufacturer: Advanced Tactile Imaging, Inc.
Email: vti(at)tactile-imaging(dot)com

Indications for Use:
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.

Relevant Publications:
1. van Raalte H, Egorov V. Characterizing female pelvic floor conditions by tactile imaging. International Urogynecology Journal 2015; 26(4): 607-9, with Video Supplement.
2. Incontinence: Tactile imaging for quantifying vaginal elasticity in prolapse. Nature Reviews Urology 2012; 9(2): 60.
3. Egorov V, van Raalte H, Lucente V. Quantifying vaginal tissue elasticity under normal and prolapse conditions by tactile imaging. International Urogynecology Journal 2012; 23(4):459-66.
4. Sarvazyan A., Egorov V. Mechanical imaging - a technology for 3-D visualization and characterization of soft tissue abnormalities: A Review. Current Medical Imaging Reviews 2012; 8(1): 64-73.
5. Egorov V, van Raalte H, Sarvazyan A. Vaginal Tactile Imaging. IEEE Transactions on Biomedical Engineering 2010; 57(7):1736-44.

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Vladimir Egorov
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