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Gynedil, our optimized solution for cervical dilation.

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An innovative solution for women to explore to make informed decisions on the best approach for cervical dilation.

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The Device
GYNEDIL FEATURES
Gynedil is light, mobile, easy for handling and independent of the provider's experience.
Gamma sterilized and single-use device that reduces the risk of intrauterine infection.
The dilation takes an average of 30 seconds which significantly shortens the duration of the entire procedure.
Only one insertion is performed and no redilatation is required.
The device is patent protected and CE marked.
Flexible tip allows penetration in the cervical canal with minimal resistance and adaption to curvature of the patient’s anatomy, but still firm enough to enable easy insertion.
Technical Details
01
- The manual hydraulic pump - is similar to a water pistol made of medical plastic. The instrument handle includes a distilled water container and piston pump which can produce a pressure of around 20 bar inside an inflated balloon*. When you pull the trigger the piston pump injects pressurized distilled water into the balloon dilator.
*The average resistance that a cervix provides is 8 bar. So, Gynedil is strong enough to overcome that resistance and achieve the desired dilation diameter.
02
- The balloon dilator - consists of an elastic membrane strengthened by reinforced fabric and connected to the pump. The balloon is in medical-grade silicone, latex-free, causes no allergies or irritation. The deflated balloon is 6 cm long and 4.5 mm in diameter**.
**Achieved dilation of the inflated balloon is 12 mm and achieved dilation of the cervical canal after removing the balloon dilator is 10 mm.
How It Works
Video
Graphical
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Key Advantages
FOR GYNECOLOGISTS
All gynecologists can perform dilation using Gynedil® with less risk and its applicability is independent of the provider's experience.
  • Gynedil is intended for single use, so there is reduced risk of intrauterine infection.
  • Only one insertion is performed and no redilation is required.
  • Dilation with Gynedil takes between 20 to 30 seconds which shortens the duration of the whole procedure.
  • Total comfort for the doctor because the risk of cervical tissue damage is significantly reduced.
FOR PATIENTS
Symptoms associated with "cervical incompetence" were found in 75% of women who had violent dilation during termination of pregnancies1.
  • Gynedil's build reflects an innovative approach that enables a more effective and less traumatic dilation.
  • Its flexible balloon dilator allows penetration in the cervical canal with minimal resistance and adaptation to curvature of the patient's anatomy.
    This prevents the risk of infection, laceration of the cervix, perforation of the uterus and cervical incompetence.
1.A survey by Dr. Ren, "Cervical Incompetence - Aetiology and Management," Medical Journal of Australia (December 1993 ,29), Volume 60.
Clinical Experience
Clinical trial proved that the dilation by hydraulic dilator was more effective and much less traumatic than dilation by Hegar dilators2.
The hydraulic dilator either does not cause the damage to cervical epithelium or the observed changes are of much smaller intensity and seldom frequency than those appearing when other types of dilators are used2.
The occurrence of bleeding is three times more frequent in the patients dilated by Hegar dilators, and also of larger intensity than in the group of patients whose cervix is dilated by hydraulic dilator2.
The probability of damage to the basal membrane is ten times smaller with the application of the hydraulic dilator2.
The obtained values of relative risk show that the probability of the occurrence of stromal damage is five times smaller with the application of hydraulic dilator than with the application of Hegar dilator2.
2.Vukcevic G., Comparative analysis of the damage of the cervical canal during the dilatation of the cervix by means of classical and hydraulic dilatators; Doctoral dissertation, Kragujevac 2010.