Gynesonics said it won an FDA investigational device exemption for its VizAblate system with an outpatient option for treating symptomatic uterine fibroids.
The trial will investigate the safety and effectiveness of VizAblate in treating heavy menstrual bleeding associated with symptomatic uterine fibroids, according to a press release.
VizAblate is designed to allow physicians to visualize and target fibroids within the uterus using an integrated ultrasound probe and ablate them with radiofrequency energy, Gynesonics said.
The Redwood City, Calif.-based company has CE Mark approval to market the new system in Europe and in June announced the 1st use of the device in Germany.
As many as 80% of U.S. women develop uterine fibroids by age 50, according to a press release, with some 200,000 hysterectomies performed annually because of symptomatic fibroids.
"We are pleased to have FDA approval to begin this pivotal trial thus validating the preclinical testing profile and clinical trial design for VizAblate," vice president of regulatory, clinical & quality systems Diane King said in prepared remarks. "Initiation of this study will begin in Q4 this year and will be conducted at up to 22 clinical sites with 147 patients, and upon favorable conclusion will allow the company to complete a 510k application for VizAblate with the FDA."