Technology

The Viveve System is a medical device that uses radiofrequency energy to non-surgically treat laxity at the vaginal opening. The technology is patented and radio-frequency energy has been used safely in hundreds of thousands of procedures in other non-surgical applications.

The 30-minute, in-office treatment is performed by a physician; it is a straightforward, simple procedure and does not require general or local anesthesia. The treatment tip is placed against the vaginal opening, cooling the surface of the tissue while the RF energy is delivered into the tissue where energy is converted to heat. This heat remodels and increases collagen density in the vaginal tissue itself. The combined effect creates an increased feeling of tightness from the hymenal ring to several centimeters inside the vagina. There are three components to the Viveve System: the RF generator that has been optimized for use in an office setting; the hand piece that is specifically designed for the application; and the disposable tip.

Device Thumb 1  Device Thumb 2

We believe the Viveve System has three features that when combined make this a well-tolerated, safe and efficacious procedure:

  • Monopolar RF – one active electrode (the treatment tip) and one inactive electrode (a return pad that is placed on the patient during the procedure)
  • Volumetric heating – The energy is dispersed across the entire face of the treatment tip (about 2cm), which heats a volume of tissue up to 3mm beneath the tissue surface
  • Reverse thermal gradient – The surface of the tissue is cooled and protected while the heat penetrates into the tissue

The treatment is delivered in multiple 3-second pulses. Each pulse consists of:

  • Pre-cooling of the superficial tissue
  • RF delivery to deeper tissue
  • Post-cooling of the superficial tissue

The Viveve procedure under development will offer the following benefits:

  • Is non-surgical, with no topical or general anesthesia required
  • Takes less than 30 minutes in your doctor’s office
  • Is designed as a single treatment
  • Requires little to no downtime. You can quickly return to your normal daily activities

The Viveve procedure is not cosmetic. It is a treatment that addresses the quality of life condition of loose vaginal tissue and may result in improvement in women’s sexual satisfaction.