Gynesonics touts 1-year pivotal IDE Sonata trial data

Gynesonics yesterday released 12 month results from the FDA investigational device exemption pivotal trial of its Sonata system intended for diagnostic intrauterine imaging and the transcervical treatment of symptomatic uterine fibroids. Results from the trial were published in the journal Obstetrics and Gynecology, the Redwood City, Calif.-based company said. The company’s flagship Sonata System is a uterus preserving, incision-free uterine fibroid treatment designed to treat fibroids transcervically with radiofrequency energy. The system combines both an intrauterine ultrasound system with a proprietary radiofrequency ablation device, Gynesonics added. “It is exciting to have the final one-year results from the Sonata Pivotal IDE Trial published in Obstetrics and Gynecology. We are appreciative of the investigators and their commitment to advancing options in women’s healthcare by studying the outcomes of our technology for the treatment of symptomatic uterine fibroids in the Sonata Trial. This is an important milestone and it comes on the heels of our recently announced substantial equity financing. We will continue to invest in high quality clinical and health economic outcomes research to help ensure access to the Sonata treatment for women suffering from symptomatic uterine fibroids in the United States and globally,” prez & CEO Christopher Owens said in prepared remarks. In the 147-patient Sonata trial, investigators explored the use of the Sonata...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Women's Health Gynesonics Source Type: news