10.22.14
Redwood City, Calif.-based Gynesonics Inc., a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, has received approval from the U.S. Food and Drug Administration (FDA) of an investigational device exemption (IDE) for a pivotal clinical trial. The Sonata trial will evaluate its newly-designed Vizablate system, which 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.
“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 510(k) application for Vizablate with the FDA.”
The Sonata trial will investigate the safety and effectiveness of VizAblate in treating heavy menstrual bleeding associated with symptomatic uterine fibroids.
“Receiving FDA IDE approval of the Sonata trial is a significant strategic milestone for Gynesonics,” said President and CEO Chris Owens. “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 United States to participate in the Sonata U.S. 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.”
The company has also recently received CE mark approval to market the new system in the European Union, and the first European patient of the system was treated in June.
“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 510(k) application for Vizablate with the FDA.”
The Sonata trial will investigate the safety and effectiveness of VizAblate in treating heavy menstrual bleeding associated with symptomatic uterine fibroids.
“Receiving FDA IDE approval of the Sonata trial is a significant strategic milestone for Gynesonics,” said President and CEO Chris Owens. “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 United States to participate in the Sonata U.S. 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.”
The company has also recently received CE mark approval to market the new system in the European Union, and the first European patient of the system was treated in June.