PALO ALTO, California., February 14, 2019 – Today, Sciton Inc., a leading manufacturer of medical and aesthetic laser and light source technologies, announced that it has received an expansion of the clearances for its medical device license issued by Health Canada for their diVaⓇ product to include a new indication “for the treatment of the symptoms of Genitourinary Syndrome of Menopause (GSM)” in peri and post-menopausal women. Among other information, Sciton submitted clinical evidence for Health Canada’s review and on February 11, 2019, Sciton received notification from Health Canada for this new indication for diVa.
Genitourinary Syndrome of Menopause, is a term developed in 2014 by experts from the International Society for the Study of Women’s Sexual Health (ISSWSH) and the North American Menopause Society (NAMS) (Portman DJ1, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel, Menopause. 2014 Oct;21(10):1063-8)
“The genitourinary syndrome of menopause (GSM) is a new term that describes various menopausal symptoms and signs including not only genital symptoms (dryness, burning, and irritation), and sexual symptoms (lack of lubrication, discomfort or pain, and impaired function, but also urinary symptoms (urgency, dysuria, and recurrent urinary tract infections).”
It is estimated that as many as 85 % of postmenopausal women have experienced a menopause-related symptom in their lifetime (Woods NF, Mitchell ES. “Symptoms during the perimenopause: prevalence, severity, trajectory, and significance in women’s lives”, Am J Med. 2005;118(Suppl 12B):14–24. doi: 10.1016/j.amjmed.2005.09.031).
“Every day in my practice, women seek answers and options that will provide them relief from the symptoms they are experiencing from GSM. Plainly stated, these symptoms affect their daily lives, intimate relationships, and quality of life. In my practice, diVa has been an ideal non-surgical and effective option to improve their vaginal health and allow them to feel these symptoms are not the norm that they must live with,” states Andrew Steinberg, M.D., Urologist, Steinberg Urology, Montreal, QC
“We are gratified to receive notification of this significant milestone and recognition from Health Canada related to the effectiveness of the diVa Vaginal Laser for GSM. Even more significant is being able to reach millions of women in Canada who will benefit from customized treatments of diVa’s hybrid fractional laser technology”, says Todd Sternbach, Vice President of the Women’s Health Group at Sciton.
ABOUT THE diVaⓇ PRODUCT
diVaⓇ is the world’s first hybrid fractional laser in women’s gynecological and genitourinary health. diVa expands the broad range of Sciton’s JOULE™ platform capabilities to address a woman’s health challenges. diVaⓇ is the only device available that includes HPA (High Precision Automation) technology to ensure the safest and best treatment outcome for patients and predictability for the operator. Additionally, diVaⓇ‘s dual-wavelength hybrid technology and tunability allow operators to customize treatments based on a patient’s age, symptoms, and desired results. This ability makes it unique by delivering selected energy levels to different layers of vaginal tissue. diVa is performed as an office-based procedure, often in less than five (5) minutes and requiring no sedation. diVa has been performed successfully throughout the world many thousands of times.
ABOUT SCITON
Sciton, Inc., located in Palo Alto, California, is a totally employee-owned medical device company established in 1997 by co-founders Jim Hobart, Ph.D., and Dan Negus, Ph.D. Sciton is committed to providing best-in-class laser and light solutions for medical professionals who want superior durability, performance, and value. Sciton offers aesthetic and medical devices for women’s health, fractional and full-coverage skin resurfacing and skin revitalization, phototherapy, vascular and pigmentation lesions, scar reduction, acne, body contouring, and hair reduction. Sciton operates worldwide with direct sales forces in the United States, Canada, Japan, Australia, and distributor partners in more than 45 countries. For more information and a complete listing of Sciton systems, visit sciton.com.