Health Canada Approves Two New Gynecological Indications For Candela’s CO2RE Laser Platform

Health Canada has approved Candela’s CO2RE laser for the treatment of genitourinary syndrome of menopause and stress urinary incontinence in adult women.

Health Canada has approved Candela’s CO2RE laser for the treatment of genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) in adult women.

The CO2RE laser, a single CO2 platform equipped with 6 treatment modes and multiple customized handpieces, is indicated for use in 10 medical specialties, including dermatology, aesthetics, and gynecology. The CO2RE laser with Intima handpiece and module provides practitioners a simple and efficient gynecological solution for the treatment of the introitus, vaginal canal, and external genitalia.

"Women's genitourinary health has been a neglected area in medicine causing women to suffer in silence, and I am proud to see the work being done to develop new treatments for vaginal and urinary disorders," says Dr. Macrene Alexiades, MD, PhD, Founder and Director of Dermatology and Laser Surgery Center of New York, in a news release. "The Canadian approvals of the CO2RE laser for the indications of genitourinary syndrome of menopause and stress urinary incontinence are significant steps forward in providing access to treatments that positively impact women and their quality of life."

The CO2RE laser offers women who are not compliant with, are not able to, or who do not wish to use hormonal or topical therapies, an alternative treatment option for the symptoms associated with GSM. For females living with SUI, the CO2RE laser provides a minimally invasive alternative to physical therapy for pelvic floor rehabilitation and more invasive options in the form of surgical intervention.

"At Candela, we are dedicated to changing lives through the innovation of energy-based solutions that enable the treatment of many dermatologic conditions, including those in gynecology," states Geoff Crouse, Chief Executive Officer of Candela. "The Canadian approvals of the CO2RE laser for the indications of GSM and SUI demonstrate our commitment to this mission. We are proud to have brought forward a clinically-proven, nonsurgical, and hormone-free option for women and the practitioners treating them."

"This approval is a very exciting milestone for women's health," adds Karen Desrosiers, MD, a board-certified Ob/Gyn at Moncton Hospital in Moncton, New Brunswick, Canada. "While over 50 percent of menopausal women experience symptoms of GSM and as many as 35 percent of women are affected by SUI, many are left untreated, resulting in a diminished quality of life. Continued clinical research on the positive outcomes achieved from treatment with energy-based devices and subsequent approval of expanded indications by regulatory bodies will improve patient access to these life-changing gynecological procedures."

Health Canada approval for the two indications is based on extensive clinical research in more than 100 peer-reviewed journals published worldwide since 2001. A meta-analysis from 3 studies evaluating the use of the CO2RE laser with Intima handpiece for the treatment of vulvovaginal atrophy confirmed that all patients evaluated at the three-month follow up saw significant improvements in vaginal health index (VHI) as compared to baseline with a mean improvement of 9.5 ± 3.3 (P < 0.001) after three treatments. Clinical findings also suggested significant improvements in additional symptoms associated with genitourinary syndrome of menopause including itching, burning sensation, and dyspareunia. A peer- reviewed study assessing the efficacy of the use of the CO2RE laser for the treatment of stress urinary incontinence and severity of urinary incontinence demonstrated significant improvements in UI severity (p=0.0035) after the second treatment.