Gynesonics Announces Publication of Final SONATA IDE Pivotal Trial Results in the Journal, Obstetrics and Gynecology

Published: January 10, 2019

By Gynesonics

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jan 10, 2019--Gynesonics, a women’s healthcare company and the developer of the Sonata ® system for the treatment of uterine fibroids (also known as leiomyomas) today announced the publication of the SONATA IDE Pivotal Trial 12-month results in the January edition of Obstetrics and Gynecology, the official publication of the American College of Obstetricians and Gynecologists (ACOG).

The article, Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas, reports the final 12-month results from the SONATA Trial. Treatment of 147 enrolled patients was performed using the company’s Sonata system, a proprietary and innovative treatment device allowing incisionless transcervical radiofrequency energy ablation of uterine fibroids under intrauterine ultrasound control, at 22 outpatient clinical research sites, including 21 in the U.S. and one in Mexico. Highlights from the publication include the following final 12-month outcomes: 99% of patients were free from surgical reintervention for heavy menstrual bleeding 97% were satisfied with the treatment and would recommend it to family or friends 96% reported improved symptoms 95% had a reduction in menstrual bleeding 65% had at least a 50% reduction in menstrual bleeding Additionally, the mean length of stay, including procedure time, was 2.5±1.2 hours, and 50% of patients returned to normal activity the next day (mean 2.2±2.2 days). There were no device-related adverse events.

“Uterine fibroids are a common problem that reduce the quality of life for women in the United States today. The SONATA pivotal clinical trial outcomes, along with the data from other published clinical outcome studies using the same technology, support offering sonography-guided transcervical uterine fibroid ablation as a treatment option to appropriate patients suffering from symptomatic uterine fibroids,” stated Scott Chudnoff, MD, MSc, FACOG, Chair, Department of OB/GYN at Stamford Health (Stamford, CT), a SONATA Trial investigator and lead author on the publication. He continued, “This transcervical, uterine sparing approach avoids some of the risks of other treatment options, with minimal disruption in our patients’ lives.”

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