April 16, 2021
Gynesonics today announced the publication of its peer-reviewed journal article, “Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results,” in the journal Medical Devices: Evidence and Research.
The article reported that of 241 fibroids treated by the Sonata® System, 10 percent were submucous, 52 percent transmural, 28 percent intramural, and 10 percent subserous. Ablated fibroid diameters ranged from <1 cm to >10 cm, with 27 percent of fibroids having maximum diameters >5 cm. Additionally, the preliminary results indicated the Sonata System maintained its established safety profile with very low device-related adverse event and serious procedure-related adverse event rates of 0.6 percent for both measures. These initial results corroborate those from previous clinical trials, as well as more than 1,800 commercial cases worldwide.
“The SAGE registry represents the largest clinical study to date of transcervical fibroid ablation (TFA) and will generate up to 2,500 patient-years of outcomes data,” said Dr. Ladina Christoffel, Head of Gynecology and Obstetrics at the Spital Oberengadin-Schweiz in Samedan, Switzerland.
Christoffel added, “The real-world outcomes derived from SAGE will further strengthen the existing evidence on the durability of TFA and the Sonata System in providing meaningful relief from uterine fibroid symptoms as well as having important positive clinical and economic implications for patients, physicians and healthcare payers. It is impressive to see the wide range of fibroid types treated, as most of these could not be treated by operative hysteroscopy, and TFA, as performed by the Sonata System, allows women to avoid the much more invasive options of myomectomy or hysterectomy.”
In the SAGE Registry, eligible patients are adult women (age ≥18 years) with symptomatic uterine fibroids who select TFA for treatment of their fibroids. No limitations are imposed on maximum patient age, fibroid type, fibroid size, prior surgical history, baseline symptom severity, or desire for future fertility. The registry will follow women for 5 years, after which a comprehensive characterization of long-term, real-world outcomes of TFA will be possible.
“We are incredibly pleased to see the SAGE Registry initial results indicate that in real world conditions, women with a very wide range of fibroid types, locations and sizes can be successfully treated with TFA utilizing the Sonata System,” said Taraneh G. Farazi, Ph.D. and Vice President, Clinical Affairs at Gynesonics. “These safety results are completely aligned with data from multiple clinical studies utilizing Sonata. For the millions of women who want to avoid more invasive procedures such as myomectomy or hysterectomy, there is now a safe and effective alternative treatment for their symptomatic fibroids, with excellent long-term results.”