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Gynesonics obtains FDA approval for VizAblate System’s IDE clinical trial

Womens healthcare company Gynesonics has secured approval from the US Food and Drug Administration (FDA) to commence a pivotal investigational device exemption (IDE) trial, Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA Trial), for VizAblate System.

The system has been developed to provide women with a transcervical, incision-free, outpatient option to invasive surgical procedures such as hysterectomy for the relief of symptomatic uterine fibroids.

Gynesonics regulatory, clinical and quality systems vice-president Diane King said: "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.

"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."

The SONATA trial will evaluate the safety and effectiveness of VizAblate in treating heavy menstrual bleeding associated with symptomatic uterine fibroids.

Gynesonics president and CEO Chris Owens said: "Receiving FDA IDE approval of the SONATA trial is a significant strategic milestone for Gynesonics."

Under intrauterine sonography guidance, VizAblate uses radiofrequency energy to ablate fibroids, said Gynesonics.

The system has already received CE mark approval to market in the European Union.