Gynesonics declares IDE Trial results for incision-free treatment of Uterine Fibroids

Having forayed into development of minimally invasive solutions for symptomatic uterine fibroids, women’s healthcare company, Gynesonics announced the results for their pivotal IDE Trial for the Sonata® system for the incision-free treatment of uterine fibroids thereby paving way for US FDA 510 (k) clearance of the Sonata system in the U.S. The Sonography-Guided Transcervical Fibroid Ablation (SONATA) trial is a prospective, longitudinal, multicenter trial evaluating the safety and effectiveness of the company’s investigational Sonata system in the treatment of women suffering from fibroid related heavy menstrual bleeding (HMB). A total of 147 patients were enrolled at 22 centers in the U.S. and Mexico. Some of the 12 -month clinical outcomes enumerate that 99% of trial patients did not entail surgical intervention from HMB, 94 % of patients witnessed the reduction of bleeding, 64% of patients achieving more than 50% reduction in bleeding.  97% of patients were satisfied with the procedure and would likely recommend it to friends.

Most of the patients claimed bouncing back to routine activities the day after the procedure.

Scott Chudnoff, Chief of OB/GYN at Stamford Hospital, Stamford, CT a principal investigator in the SONATA trial, stated, “The actual results achieved in the SONATA trial far exceed the required thresholds established by the FDA for the co-primary endpoints of reduction in menstrual bleeding and freedom from surgical reintervention for bleeding. These results, along with the impressive levels of patient satisfaction and rapid return to normal activity achieved, clearly demonstrate the potential for Sonata as a first line treatment for symptomatic fibroids.”