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SONATA FDA IDE Pivotal Trial Long Term Results Published in the Journal of Gynecologic Surgery.

October 13, 2020

SONATA FDA IDE Pivotal Trial of Transcervical Fibroid Ablation (TFA) for Symptomatic Uterine Myomata” three-year results have been published in the Journal of Gynecologic Surgery. The news was announced today by Gynesonics®.

SONATA FDA IDE Pivotal Trial outcomes reported in the paper build upon the previously published 12-month and 24-month outcomes, demonstrating the sustained durability of patient benefits through three years which include a significant reduction in fibroid related symptoms.

Andrea Lukes, M.D., MHSc, FACOG Founder and CEO of Carolina Women’s Research and Wellness Center, and the first author on the SONATA® three-year publication, explained, “Our center is committed to advancing women’s health care, including participating in clinical trials to evaluate promising new medical and surgical innovations. I wanted to be an investigator in the SONATA trial because of the advancement the Sonata technology represents as a minimally invasive, transcervical fibroid treatment. Early in the trial, it was easy to see the patient benefits provided by Sonata. From my patients’ perspectives, TFA has established an excellent safety record associated with significant improvements in fibroid symptoms and quality of life. The women at my center returned to normal activity and work after the procedure very quickly; this is incredibly important to them given most do not want a lengthy recuperation. The Sonata System is used transcervically; there are no incisions and patients tend to leave within 1-2 hours from the start of their procedures. When you consider the safety and tolerability of the procedure combined with the impressive three-year trial outcomes showing a significant and durable improvement in symptoms and quality of life, this represents an important and highly positive advancement in women’s health. Healthcare providers, in particular gynecologists, should consider Sonata when discussing treatment options for women with symptomatic fibroids.”

The journal article,Three-Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata,” reports the three-year clinical outcomes of the prospective, longitudinal, multi-center SONATA trial that enrolled 147 patients at 22 centers (21 in the United States, one in Mexico). The trial followed patients through 36 months, with a notable 90 percent of enrolled patients accounted for at three years. The outcomes included:

  • 94 percent of patients reported satisfaction with the TFA treatment at three-years (97 percent at 12-months)
  • Health-Related Quality of Life (HRQL) scores improved significantly from 40 at baseline to 78 at three-months, and to 83 at three-years (P<0.001 at all time points)
  • Symptom severity scores significantly decreased from 55 at baseline to 27 at three-months, with continued improvement to 22 out to three-years (P<0.001 at all time points)
  • All work productivity and activity level measures related to fibroid symptoms improved significantly through three-years, including work absenteeism (reduced by more than 50 percent), a 76 percent reduction in work impairment, and a 76 percent reduction in physical activity impairment
  • The rate of surgical reintervention for heavy menstrual bleeding at three years remained low at 8.2 percent. This follows previously reported surgical reintervention rates of 0.7 percent and 5.0 percent at 12 months and 2 years, respectively

“We appreciate the commitment and follow-through of the 26 clinical investigators at the 22 trial centers who contributed to the SONATA FDA IDE Pivotal Trial. These long-term results from SONATA, along with the previously published VITALITY study, provide significant, durable long-term outcomes through five years,” commented Gynesonics President and CEO Chris Owens. “Long-term peer-reviewed published evidence is a critical component and request from physicians, patients and payors when choosing to adopt a new technology. These markedly improved and sustained clinical outcomes through three years in the SONATA Pivotal Trial have been well-received by the physician community. We now have one-, two-, three- and five-year long-term outcomes published in peer-reviewed journals, showing our commitment to understand the long-term results associated with the Sonata procedure. This further demonstrates why Sonata should be among the immediate considerations for treatment when managing women who are suffering from symptomatic uterine fibroids. An alternative to more invasive fibroid treatment options that provide a durable relief in symptoms while also resulting in a positive health economic benefit to our healthcare system is needed. Sonata provides that solution.”

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