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.
Media
courtesy: Gynesonics, Current obstetrics and gynecology reports
