Gynesonics Announces Expert Group of European Gynecologic Surgeons Publishes Consensus on the Broad Use of the Sonata Technology in a New Treatment Strategy for Symptomatic Fibroids
Redwood City, CA, August 11, 2021 – Gynesonics®, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today a group of 12 surgeons from multiple fibroid treatment centers in Germany, Austria and Switzerland have published a review of symptomatic fibroid treatments, and recommended a treatment algorithm based on fibroid type and location.1 In this algorithm, Gynesonics’ Sonata® System was placed as the primary treatment procedure for 4 of 9 fibroids types (FIGO types 2, 3, 4 and 2-5) encompassing over 60% of fibroid occurrence. In the remaining applicable fibroids (FIGO types 1, 5 and 6), the recommendation was that Sonata should be considered for certain common scenarios such as larger and deeper fibroids that may be more difficult to treat surgically, including staged treatments or for women that have multiple fibroids. This supports utilizing Sonata as a treatment for more than 80% of fibroid types. This recommendation came shortly before The American College of Obstetricians and Gynecologists (ACOG) published new guidelines also supporting the use of Transcervical Radiofrequency Ablation (TRFA) for the treatment of symptomatic fibroids. Sonata is the only commercially available TRFA system. This expert consensus led to a new recommended treatment algorithm for each fibroid type:
“When we began evaluating transcervical radiofrequency fibroid ablation (TRFA) using Sonata, we quickly learned that this technique, a completely incision free procedure, would be applicable for a wide range of fibroid types and patients,” said Prof. Dr. med Thomas Römer, Evangelisches Klinikum Köln-Weyertal, in Cologne, Germany. “This creates the opportunity for many more women to take advantage of the extremely fast recovery and durable results. This procedure can be placed in the operating theatre workflow quickly and in a straightforward manner.”
The Sonata technology platform integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids. The Sonata Treatment is a breakthrough alternative to hysterectomy and myomectomy, and can treat a wider range of fibroid types, sizes, and locations than hysteroscopic myomectomy. Fibroids are treated from within the uterus, so treatment with the Sonata System requires no incisions, no tissue is surgically removed, and the uterus is retained.
“This new fibroid treatment algorithm will be useful for physicians in the United States who are now evaluating where Sonata should be placed in their clinical protocols,” said Kelly Roy, MD, Arizona Gynecology Consultants, Assistant Program Director FMIGS Banner University Medical Center and Clinical Assistant Professor, University of Arizona College of Medicine-Phoenix. “This is an unprecedented opportunity to build on the clinical experience of these surgeons, who have performed over 1000 Sonata procedures in multiple, established fibroid treatment centers. This published experience will allow physicians to create a protocol more rapidly and confidently, including patient selection criteria, utilizing Sonata (TRFA). This review is aligned with the recent practice guidance by ACOG that recognizes the role of transcervical fibroid ablation as an important option for women in the treatment of symptomatic fibroids.2 Additionally, the Sonata System allows the surgeon to treat the most common types of myomas, which are not accessible by any other transcervical method, and therefore Sonata is the only fibroid ablation system noted in the ACOG guidelines that can avoid abdominal incisions.”
After reviewing published clinical results, including procedure time, recovery time, complication rate and reintervention rate, the authors found the TRFA procedure to be favorable in the majority of characteristics.