FDA Approval for Vaginal Tightening Treatment Clinical Studies

Viveve Announces FDA Approval to Continue Studies on Vaginal Tightening

Vaginal looseness or “laxity” that causes loss of sexual sensation is a medical condition affecting more than 40% of women. Yet, because many women are embarrassed to talk about it – coupled with the fact that the medical community was male dominated until relatively recently – this problem was largely ignored. And when vaginal laxity was addressed, dangerous and invasive surgery was the only option.

The good news is that new vaginal tightening treatments for vaginal laxity are finally available, very safe, and do NOT require painful surgery.

12 Month Geneveve Vaginal Tightening Treatment Study

Viveve Medical, Inc. is a women’s health company dedicated to advancing medical solutions that improve women’s quality of life. Viveve has patented the GENEVEVE™ treatment, which uses clinically-proven cryogen-cooled, monopolar radiofrequency (CMRF) technology to stimulate the production of collagen in areas of the vagina and pelvic floor. By “rejuvenating” the tissues in these areas with radio frequency, the vagina can be “tightened” – leading to improved sexual sensation and function.

Geneveve already has international regulatory approvals and clearances for treating vaginal laxity and/or improvement in sexual function indications in more than 55 countries around the world.

An initial clinical study was also very successful, and the safety data was sufficient for the FDA to grant continued enrollment of up to 100 subjects in second stage of sexual function trial. In March, Viveve received FDA approval to proceed with a second clinical trial (VIVEVE II) to assess the safety and effectiveness of the Viveve® System for the improvement of sexual function in women following vaginal childbirth.

Following FDA review of the second stage of safety data, Viveve plans to expand the study and continue enrollment of up to 250 patients to study the positive effects of Geneveve vaginal tightening treatment on vaginal laxity and sexual sensation.

Radiofrequency has been FDA approved for almost a decade for tightening laxity in the face. And in the initial study absolutely no complications, side effects or risks were found. In the second phase of the study female patients will also be assessed for safety – as well as for improvement in “FSFI”: Desire, Lubrication, Orgasm, Arousal, Satisfaction, and Pain.

Top Detroit Area Vaginal Tightening Treatment

Dr. Ali has helped hundreds of women in the Detroit area stop bladder leaks & improve sexual intimacy with just a single 30 minute Geneveve vaginal tightening treatment.

It is an affordable, painless, procedure performed in our Birmingham, MI (Detroit area) medical office. There is no downtime, and you will begin to notice vaginal improvement within just a few weeks.

Call us for a free, discreet, confidential vaginal rejuvenation consultation and see if Geneveve is right for you!

Detroit Area Vaginal Tightening Consultation: 248-335-7200