Gynesonics, Inc., a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, has received U.S. FDA approval for an investigational device exemption (IDE), allowing it to commence its pivotal trial. The newly-designed VizAblate® System will be studied in the so-called SONATA (Sonography Guided Transcervical Ablation of Uterine Fibroids trial. The system is designed to provide women with a transcervical, incision-free, outpatient option to invasive surgical procedures such as hysterectomy for the relief of symptomatic uterine fibroids.
According to the medical literature, in the United States, about 70-80 percent of women in the US will develop uterine fibroids by age 50. In addition, approximately 200,000 hysterectomies are performed in the United States each year because of symptomatic fibroids, according to the New England Journal of Medicine.
Gynesonics’ VizAblate system uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance. The VizAblate device and software allows users to visually target specific fibroids and optimize ablations within them. VizAblate’s unique transcervical access is straight-forward, is associated with short procedure times, requires minimal in-procedure assistance, and is incision-free. 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.
The device is already CE Marked and a first patient in Europe was treated in June this year. Gynesonics says its VizAblate System offers a distinct alternative to power morcellation and other major surgical and radiological approaches for the treatment of fibroids.
The SONATA trial will investigate the safety and effectiveness of VizAblate in treating heavy menstrual bleeding associated with symptomatic uterine fibroids.
“We are pleased to have FDA approval to begin this pivotal trial thus validating the pre-clinical testing profile and clinical trial design for VizAblate,” said Diane King, Vice President of Regulatory, Clinical and Quality Systems for Gynesonics. “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.”
“Receiving FDA IDE approval of the SONATA trial is a significant strategic milestone for Gynesonics,” said Chris Owens, President and Chief Executive Officer. “We are excited by the positive outcomes with VizAblate in the FAST-EU clinical trial, as well as the level of interest displayed by leading gynecologists throughout the U.S. to participate in the SONATA US IDE trial. We will continue to collaborate with all parties to make this breakthrough technology available to physicians and to the millions of women suffering from symptomatic fibroids in the United States and around the globe. Our VizAblate System is designed to offer gynecologists a new approach to the management of symptomatic uterine fibroids; for patients VizAblate may offer a much needed, precisely targeted therapy without the need for surgery.”
Source: Gynesonics, Inc., Business Wire