A long-term retrospective study of patients treated with Gynesonics’ Sonata uterine fibroid treatment system revealed low rates of surgical reintervention, improved symptom severity and quality of life, the company said today.
Patients at the study site in Monterrey, Mexico were treated with the Sonata system, designed to provide incisionless transcervical radiofrequency energy ablation of uterine fibroids under intrauterine ultrasound guidance. The mean follow-up period for the patients enrolled was 5.4 years.
Highlights from the study include:
- No surgical reinterventions in the first 3.4 years.
- Annualized surgical reintervention rate per year of 2.2%.
- 11.8% cumulative reintervention rate through 5.4 years average follow-up.
- 37 point mean improvement in symptom severity score at follow-up.
- 49 point mean improvement in health-related quality of life at follow-up.
“We have evaluated many new fibroid treatment innovations in our facility and are especially impressed with the patient results achieved with Sonata over this extended time frame,” said Jose Gerardo Garza-Leal, M.D., of the Universidad Autonoma de Nuevo Leon in Monterrey in a prepared statement from Gynesonics. “Such lasting results are even more impressive considering the low risk and quick recovery our patients experienced with the Sonata procedure, especially when compared to other fibroid treatment alternatives.”
Redwood City, Calif.-based Gynesonics said its Sonata system platform provides transcervical access to a wide range of fibroid types, most of which cannot be treated with current operative hysteroscopy methods.
In January, the company released 12-month results from an FDA investigational device exemption pivotal trial of Sonata at 21 outpatient sites in the U.S. and a single site in Mexico. Data from the trial indicated that 99% of patients required no surgical reinterventions for heavy menstrual bleeding, with 97% reporting satisfaction with the treatment. Symptom improvement was reported by 96% of patients, with 95% reporting a reduction in menstrual bleeding. A total of 65% of the trial’s 147 patients reported at least a 50% reduction in menstrual bleeding.
The National Institutes of Health estimate 200,000 hysterectomies are performed in the U.S. each year specifically to address symptomatic uterine fibroids. With an estimated volume of more than 1 million annual global uterine fibroid procedures, Gynesonics projects a $3 billion-$4 billion global market opportunity for its Sonata system, including a market opportunity of more than $1 billion in the U.S. alone.