Gynesonics today released results from the pivotal FDA investigational device exemption cleared trial for its Sonata system designed for the incision-free treatment of uterine fibroids, touting a 99% freedom from surgical reintervention for heavy menstrual bleeding.
The Redwood City, Calif.-based company’s Sonata trial is a prospective, longitudinal, multi-center trial exploring the safety and effectiveness of its Sonata device, which is designed to use sonograph-guided radiofrequency ablation to destroy intrauterine fibroids while preserving the uterus.
Results from the trial indicated that 99% of trial patients were free from surgical reintervention at 12 months. A total of 94% of patients treated with the Sonata reported a reduction in bleeding, with 64% achieving a greater than or equal to 50% reduction in bleeding.
Data also indicated that 97% of patients in the trial were satisfied with the procedure and would recommend it to friends, with most patients returning to normal activity the day after the procedure.
“The actual results achieved in the Sonata trial far exceed the required thresholds established by the FDA for the co-primary end points 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,” principal investigator Scott Chudnoff of Connecticut’s Stamford Hospital said in a prepared statement.
“In light of the recent controversies in gynecologic surgery which are impacting access for women to existing minimally invasive fibroid treatment options, it is important that new innovations be made available. Sonata provides our patients with an incision-free transcervical treatment for most types and sizes of fibroids. The impressive patient outcomes achieved with the Sonata system demonstrate its potential to cause a paradigm shift away from more invasive surgical procedures in addressing this significant quality of life issue for women,” trial investigator Dr. Charles Miller said in prepared remarks.
“While these impressive results achieved with Sonata in this pivotal trial are an important milestone for women and physicians, it is the consistency of the clinical effect of our technology achieved when compared alongside the previously published FAST-EU trial that is truly noteworthy. Considering these two prospective, multicenter trials were comprised of several disparate patient populations across two continents, and performed by a broad range of physician operators across various healthcare delivery systems and clinical settings, the consistency of these results is remarkable. The reproducible results highlight the robustness of the Sonata platform design and its potential to become a new standard of care for fibroid treatment,” prez & CEO Chris Owens said in a press release.
Last month, Gynesonics said it submitted its 510(k) Premarket Notification to the FDA for its Sonata System.