FDA clears Sonata ultrasound system for transcervical, incision-free, uterus-preserving treatment for uterine fibroids

Gynesonics, a women’s healthcare company located in Redwood City, CA received FDA clearance for its Sonata (Sonography-Guided Transcervical Fibroid Ablation) System ® for non-invasive, transcervical, uterus-preserving treatment for symptomatic uterine fibroids. The Sonata System has CE Mark and is already approved for sale in the European Union.

The Sonata system combines a miniature, reusable, high-resolution intrauterine ultrasound probe (IUUS) with a single-use disposable Radiofrequency Ablative (RFA) handpiece with an introducer and needle electrode array.  The RFA handpiece is equipped with a proprietary Graphical Guidance Software (GGS) provides the operating gynecologist with real-time graphics overlay on the live ultrasound image for selecting the deployment length, width and position of the ablation guide.

The RFA handpiece and IUUS probe lock together to form a single system for an incision-free approach to the outpatient treatment of symptomatic fibroids. 

Once the fibroid is identified by the IUUS probe, the GGS projects the ellipsoidal region where the ablation will take place (ablation zone), along with a surrounding ellipsoid (thermal safety border) where tissue temperatures will be elevated. The tissue outside the safety border remains safe during the procedure.

After securing the correct location of the needle electrodes and selecting the ablative zone, RF energy is delivered to the fibroid according to a fixed treatment cycle that is dependent on ablation size. The duration and temperature of the procedure are automatically set by the software based on the size of the fibroid.

The Sonata System can create a continuous zone of ablation from 4.0 cm wide and up to 5.0 cm long, and multiple such zones can be created within a single fibroid.

Unlike operative hysteroscopies, the system does not require continuous irrigation or distention of the uterine cavity. Only a little hypotonic solution is introduced in the cavity for acoustic coupling of the ultrasound probe.

The diameter of the treatment device is 8.3 mm which includes both the IUUS probe and RFA handpiece attached to one another and is compatible with cervical dilatation of 27 French.

Other potential devices can be attached to the IUUS probe to provide additional functions beyond ablation.

The Sonata System is designed to wholly or partially ablate fibroid types 1,2,3,4,5,6 and 2-5 by the PALM-COEIN classification system developed by the International Federation of Gynecology and Obstetrics (FIGO). 

The FDA clearance is based on results of pivotal prospective, longitudinal, multicenter IDE trial (NCT02228174). A total of 147 patients were enrolled at 22 centers in the U.S. and Mexico. All patients underwent transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using the Gynesonics Sonata System.

The results of the trial showed that 99% of study patients did not require any surgical reintervention at 12 months. A total of 94% of patients treated with the Sonata reported a reduction in bleeding, with 64% achieving a more than or equal to 50% reduction in bleeding.

The system has a 97% patient satisfaction rate with the most patient returning to the regular activity about 24 hours after the procedure.

Scott Chudnoff, Chief of OB/GYN at Stamford Hospital, Stamford, CT a principal investigator in the SONATA trial, stated, “The actual results achieved in the SONATA trial far exceed the required thresholds established by the FDA for the co-primary endpoints of reduction in menstrual bleeding and freedom from surgical reintervention for bleeding. These results, along with the impressive levels of patient satisfaction and rapid return to normal activity achieved, clearly demonstrate the potential for Sonata as a first line treatment for symptomatic fibroids.”

With its ability to ablate most types of uterine fibroids and preserve the uterus, the Sonata System represents an exciting new technology for the treatment of uterine fibroids.

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Media courtesy: Gynesonics, Current obstetrics and gynecology reports