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
“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.