FDA Approves Pivotal SONATA Study for Gynesonics VizAblate System to Treat Uterine Fibroids

October 22, 2014—Gynesonics, Inc. announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption for the pivotal SONATA trial of sonography-guided transcervical ablation of uterine fibroids to evaluate the company’s VizAblate system. The VizAblate system is designed to provide a transcervical, incision-free, outpatient option to invasive surgical procedures, such as hysterectomy, for the relief of symptomatic uterine fibroids. 

According to Gynesonics, the SONATA trial will investigate the safety and effectiveness of VizAblate in treating heavy menstrual bleeding associated with symptomatic uterine fibroids. It will be conducted at up to 22 clinical sites enrolling 147 patients beginning begin in the fourth quarter of 2014. The company expects that the trial will support an application to the FDA for 510(k) marketing clearance of the VizAblate system.

The company recently received CE Mark approval to market the new system in the European Union. In June, Gynesonics announced the successful treatment of the first patient in Europe using the VizAblate system.

The VizAblate system integrates ultrasound imaging with radiofrequency ablation in a single handheld device for the incisionless transcervical treatment of fibroids. Radiofrequency energy is used to ablate fibroids under intrauterine sonography guidance. The VizAblate device and software allow physicians to visually target specific fibroids and optimize ablations within them. Treatment with the VizAblate system is confined to the uterus—the device does not violate the uterine serosa or peritoneal cavity and is a distinct alternative to power morcellation procedures, noted the company.