Gynesonics receives EU clearance for uterine fibroid treatment
13 Jan 2011
Gynesonics, Inc., a women’s healthcare company focused on minimally invasive solutions for symptomatic uterine fibroids, has received the CE mark for its VizAblate system.
The system is intended to provide gynecologists with an incision-less procedure for the treatment of uterine fibroids associated with heavy menstrual bleeding.
It is a transcervical device that combines ultrasound image guidance with radiofrequency ablation to treat fibroids in an outpatient setting. Symptoms from uterine fibroids have been reported to affect as many as 24 million women in the European Union.
“The CE mark is an important milestone for the VizAblate System,” said Darrin Uecker, President and CEO of Gynesonics. “We are very pleased with our progress throughout 2010, and the CE mark positions us to expand our clinical base and begin commercialization in the European Union where there is strong demand from gynaecologists for our product.”
“The VizAblate System provides gynaecologists with a unique solution for treating uterine fibroids,” said Jose Gerardo Garza-Leal MD, Professor at the Universidad Autónoma de Nuevo León in Monterrey, Mexico and Principal Investigator for the VizAblate clinical studies that were completed in support of the CE mark.
“The VizAblate transcervical procedure is straightforward to perform and requires no incisions, making it appealing to gynaecologists and their patients, especially when the primary option may be a hysterectomy.”
As many as 3 out of 4 women will have fibroids during their reproductive life and, though not all will experience symptoms, it has been estimated that up to 30% will. Symptoms associated with fibroids include heavy menstrual bleeding, pelvic pain and pressure and urinary dysfunction. The most frequent surgical treatment for symptomatic uterine fibroids is hysterectomy, with approximately 250,000 hysterectomies being performed in the United States each year alone for fibroids.
The VizAblate System is currently available for investigational use only in the United States.