Gynesonics Announces Publication of Clinical Study Analysis Demonstrating Effectiveness of the Sonata System in Treating Submucous and Large Symptomatic Uterine Fibroids

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April 8, 2021

Gynesonics, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced the publication of its peer-reviewed article titled, “Transcervical Fibroid Ablation With the Sonata® System for Treatment of Submucous and Large Uterine Fibroids,” in the International Journal of Gynecology and Obstetrics.

The article is an analysis of a subgroup of patients with submucous or large fibroids from two previously published multicenter prospective clinical trials (FAST-EU and SONATA) of transcervical fibroid ablation (TFA) with the Sonata System.

Among 197 women (with 534 treated fibroids), 86% of patients with only submucous fibroids and 81% of women with large fibroids (>5 cm) experienced bleeding reduction within 3 months post-ablation.  Overall symptom severity and health-related quality of life showed sustained, significant improvements over 12 months. Additional fibroid mapping of large fibroids with magnetic resonance imaging in the FAST-EU trial showed an average volume reduction of 68%.  Among women with only submucous fibroids, the rate of surgical reintervention through one year of follow up in these 197 women was also low, at 3.7% in FAST-EU and 0.0% in SONATA.

“This analysis looked at both ends of the fibroid spectrum, starting with submucous fibroids that are traditionally treated with operative hysteroscopy, and larger fibroids that are typically treated by invasive procedures such as open or laparoscopic myomectomy and hysterectomy,” said Gregory Shifrin, M.D., FACOG.

He adds, “In particular, this analysis demonstrates that TFA is effective in improving symptoms and the quality of life in women with type 1 and type 2 fibroids as well as in women with large myomata.  Being incisionless and with a very fast recovery, this provides a treatment option for many women with fibroids, who want to avoid more invasive procedures.  It is already benefitting my own patients.”

In the FAST-EU clinical trial, 50 women received TFA for the treatment of 92 fibroids.  Of these 50 women, 42 had at least one submucous myoma and 10 women had at least one fibroid larger than 5 cm.  In the SONATA clinical trial, 147 women underwent a TFA procedure involving 442 fibroids, in which 63 women had at least one submucous myoma and 9 women had at least one fibroid larger than 5 cm.

In total, 72.5% of the 534 treated fibroids in both trials were not amenable to hysteroscopic resection because they were either intramural (45.9%), transmural (18.5%), or subserous (8.1%).  Operative hysteroscopy is also not generally useful for large submucous fibroids, and when performed can require more than one treatment session and incurs the risks of fluid overload and intrauterine adhesion formation.

Gynesonics notes among all treated patients, TFA was highly effective in reducing menstrual bleeding.  The analysis in the report demonstrates similar trends in patients with only submucous fibroids and those with large fibroids among all key measures including reduction in bleeding, reduction in Symptom Severity Score, and increase in Health-Related Quality of Life Scores at 3, 6, and 12 months.

“This analysis is critical in demonstrating how TFA with Sonata may be used in place of hysteroscopic resection and morcellation, especially with larger submucous fibroids, and instead of more invasive treatment modalities such as laparoscopic and abdominal myomectomy and hysterectomy,” said Kelly Roy, MD, FACOG, who was an investigator in the SONATA clinical trial.  “Importantly, my experience in the SONATA trial, as well as my years as a gynecologist, confirms that there are a significant number of women with multiple fibroids.  With Sonata, in a single episode of care, these women can be treated transcervically and expect a rapid recovery.”

“TFA with Sonata can be used effectively for 80% of fibroid types, making it the only transcervical therapy able to accomplish that,” said David Toub, M.D., M.B.A., FACOG, Medical Director at Gynesonics.  “The Sonata System is an incisionless substitute for more intrusive procedures, does not require general anesthesia or an overnight stay, and conserves the uterus.”

He concluded, “Thus, many women who have long deferred treatment for their fibroids because they did not want to undergo major surgery and have lengthy recoveries, now have a safe and effective option that enables them to return quickly to their normal activities.  Gynecologists can utilize Sonata as a standard fibroid treatment in place of more invasive or less versatile procedures, so that their patients, many of whom find their daily lives horribly disrupted by heavy menstrual bleeding and other symptoms, can obtain significant relief.”

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