Gynesonics, a women's healthcare company focused on minimally invasive solutions for symptomatic uterine fibroids, has received the CE mark for its VizAblate System.
The VizAblate System is intended to provide gynecologists with an incision-less procedure for the treaent of uterine fibroids associated with heavy menstrual bleeding.
The VizAblate System is a transcervical device that combines ultrasound image guidance with radiofrequency ablation to treat fibroids in an outpatient setting.
Gynesonics president and CEO Darrin Uecker said that the CE mark is an important milestone for the VizAblate System.
"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 gynecologists for our product," Uecker said.