Cynosure announced that it has received a medical device license issued by Health Canada to market MonaLisa Touch for the treatment of symptoms related to Genitourinary Syndrome of Menopause (GSM), including vaginal dryness, vaginal burning, vaginal itching, pain, dysuria and dyspareunia.
The condition affects approximately half of all postmenopausal women.
"Health Canada’s authorization of MonaLisa Touch is an important regulatory milestone for Cynosure as we continue to expand the geographic reach of this innovative and efficacious aesthetic medical technology to new markets," said Cynosure CEO Michael Davin.
"With its varied and sometimes debilitating symptoms, GSM can significantly affect quality of life. We are excited about the ability to offer the nearly 7 million mid-life and older women in Canada this potentially life-changing treatment, which we believe has the potential to rapidly become a first-line therapy for GSM."
MonaLisa Touch is a fractional carbon dioxide (CO2) laser specifically designed to help restore vaginal health in postmenopausal women as well as breast cancer survivors. The procedure is performed in an office environment without the need for anesthesia and with virtually no pain or side effects.
MonaLisa Touch, which has successfully treated thousands of patients around the world, received marketing clearance from the U.S. Food and Drug Administration in September 2014.
GSM is a comprehensive term that includes symptomatic vulvovaginal atrophy as well as lower urinary tract symptoms related to low estrogen levels1. Symptoms can be chronic and progressive and are unlikely to improve over time2,3.
In addition to the treatment of GSM symptoms, Health Canada also authorized the marketing of MonaLisa Touch for incision, excision, ablation, vaporization and coagulation of body soft tissues in gynecology and genitourinary surgery.