Gynesonics initiates VizAblate FAST-EU study for uterine fibroid treatment
Gynesonics, Inc., a women's healthcare company focused on minimally invasive solutions for symptomatic uterine fibroids, today announced the start of, and initial treatments in, the FAST-EU Trial, a multicenter clinical study to demonstrate the effectiveness of the VizAblate® procedure for the treatment of uterine fibroids associated with heavy menstrual bleeding. The VizAblate® System is the only CE marked system that combines ultrasound image guidance with radiofrequency ablation to treat fibroids transcervically in an outpatient setting. Symptoms from uterine fibroids have been reported to affect as many as 24 million women in the European Union.
“The VizAblate® System represents a new and exciting approach to treating fibroids associated with heavy menstrual bleeding and has the potential to be a very important tool for the gynecologist. We are excited to be a part of this study and to have started treatments at our center.”
Centers in the Netherlands, the United Kingdom, and Mexico are participating in the study. Professor Hans Brölmann MD, PhD, Head - Department of Obstetrics and Gynaecology, Vrije Universiteit Medisch Centrum (FREE UNIVERSITY Medical Centre) in Amsterdam, Netherlands was the first physician to treat a patient in the FAST-EU study in the European Union. "The VizAblate® System represents a new and exciting approach to treating fibroids associated with heavy menstrual bleeding and has the potential to be a very important tool for the gynecologist. We are excited to be a part of this study and to have started treatments at our center."
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