Women’s Sexual Health Device Gets Go-Ahead from Canada

Viveve is addressing an under-discussed and unmet need in women’s sexual health. The Sunnyvale, Calif.-based company has received a Medical Device License from Health Canada for its Viveve System to treat vaginal laxity in women after childbirth. Vaginal laxity is a loosening of the vaginal muscles, and may occur after childbirth, sexual intercourse, or with age. The company is marketing its device, which targets the vaginal introitus (opening), as a treatment specifically for women after childbirth. The treatment is intended to improve sexual function and pleasure.

Health Canada is the department of Canadian government responsible for public health, much like the U.S. Food and Drug Administration.

“Canada is a very important market for Viveve and presents a significant opportunity. The Health Canada approval is a key milestone in our commercialization strategy,” said Patricia Scheller, CEO of Viveve. “We are looking forward to introducing the Viveve System to gynecologists and family practitioners at the upcoming Society of Obstetricians and Gynaecologists of Canada (SOGC) Annual Clinical Meeting. Canadian physicians will now be able to offer the first ever non-surgical treatment for vaginal laxity to their patients.”

Scheller has just been announced as the new CEO of Viveve. She joins the company from Prescient Medical, where she also served as CEO. She has twenty-five years experience in the medtech industry, including with major medical device companies such as Johnson and Johnson where she was director of cardiology systems. She is well prepared for a significant product launch, having managed the launch of the first Palmaz-Schatz balloon-expandable coronary stent as director of Cordis (a JNJ company), the first major product entry into what became a $6 billion market.

The Viveve system uses low-level radiofrequency (RF) to restore collagen fibers that have been stretched or damage during vaginal childbirth. A trained physician must perform the procedure but there is no need for anesthesia, claims Viveve. The procedure is said to take 30 minutes to complete, with no recovery time necessary with the patient being able to return to normal activity immediately afterward. There are three components to the Viveve System: the RF generator; the hand piece that is specifically designed for the application; and the single-use disposable tip.

Traditional treatments for vaginal laxity, which few women opt for, have been surgical. Vaginoplasty is a surgical procedure that tightens or corrects the vaginal muscles, sometimes using tissue such as oral mucosa, skin grafts, penile skin, or intestinal mucosa. Although there are a few different methods of performing a vaginoplasty, such as the balloon vaginoplasty using a foley catheter, all of the existing methods are invasive. The Viveve system is not.

Gail Knudson, M.D., clinical associate professor at the University of British Columbia Department of Sexual Medicine, highlights a problem surrounding women’s health:

“Unfortunately, women’s sexual health concerns have not been addressed in the medical community at the same rate or with the same intensity as men’s. I am happy Viveve is introducing this procedure for women in Canada. I am also hoping physicians will see this as a reminder of the importance of talking to women about their overall sexual health and particularly changes in sexual health that may occur as a result of having children.”

In a Viveve-sponsored survey of over 400 women, nearly half of women who responded expressed concern with laxity. In 2009, a “first in woman,” non-significant risk, institutional review board-approved study using the Viveve System was conducted in the United States. All women in the study reported an improved feeling of vaginal tightness during intercourse at one, three and six months post treatment. In addition, of the women who had experienced a decrease in sexual satisfaction at least one-year post vaginal delivery, all reported an improvement in sexual satisfaction at the one, three and six-month intervals. This study was published in the Journal of Sexual Medicine in September 2010. A second study in Japan was recently completed with similarly positive results and the three month interim report can also be found on the Viveve website.

The Viveve System received the CE mark for the European market in January 2011.