Sonata® Transcervical Fibroid Ablation System
Treat symptomatic uterine fibroids with the first and only intrauterine ultrasound probe combined with radiofrequency ablation.
Overview
Documents
Training
An Incisionless Fibroid Solution
Offer your patients an incisionless, uterine-sparing fibroid treatment with the Sonata System. The real-time intrauterine ultrasound and proprietary SMART OS™ technology enables precise targeting of submucosal, intramural and most subserosal fibroids.
Access without Incisions
Ablate a wide range of fibroids in a single, incisionless, transcervical procedure.
Visualize in Real-Time
Locate fibroids with an intrauterine ultrasound probe.
Treat with Precision
Target and treat fibroids with controlled ablations using SMART OS technology.
The Sonata System
The Sonata treatment device consists of a reusable ultrasound probe connected to a single-use handpiece that delivers radiofrequency (RF) energy to ablate fibroids transcervically. Additional components include a cart, RF generator, a SMART tablet, SMART OS™ guidance software and accessories.
Radiofrequency ablation (RFA) handpiece (single-use): The RFA handpiece connects to the ultrasound probe and is used to deploy an introducer and needle electrodes that deliver RF energy to fibroids.
Intrauterine ultrasound (IUUS) probe (reusable): The IUUS probe connects to the underside of the RFA handpiece and is used to located fibroids using intrauterine ultrasound.
SMART tablet: The tablet displays real-time ultrasound imaging and SMART guides used to target fibroids. It includes a 11.6 inch touchscreen and USB port for gathering procedure data.
Radiofrequency (RF) generator: The generator delivers RF energy to the handpiece, regulates the ablation temperature, and communicates with the SMART tablet for real-time monitoring.
System cart: The cart houses the tablet, generator, power components and a storage tray.
SMART OS™ guidance software: The graphical guidance software (GGS) installed on the SMART tablet streamlines ablation planning and communication between the generator and the handpiece.
RFA handpiece cable (reusable): The three-meter detachable cable connects the RFA handpiece to the generator, which enables power to the RFA handpiece.
Dispersive electrodes (single-use): The dispersive electrodes return RF energy from the handpiece back to the generator via two flexible pads, one placed on each thigh.
Ultrasound and RFA in One Device
The first and only intrauterine ultrasound probe for locating fibroids connects directly to the underside of the RFA handpiece for controlled and precise ablation.
Radiofrequency Ablation (RFA) Handpiece
The RFA handpiece is a single-use component of the Sonata treatment device, containing the introducer and needle electrodes that deliver thermal energy to fibroids.
A. Fluid infusion port
Infuse hypotonic fluid into the endometrial cavity for necessary visualization.
B. SMART control
Adjust the ablation depth by shifting the control forward or backward and adjust the ablation zone by shifting the control side to side. The four-directional control can also function as a mouse when the IUUS probe is set to 0°.
C. Confirm button
Verify when a step in the sequence has been completed.
D. Introducer slider
Advance or retract the introducer.
E. Needle electrode slider
Deploy or retract the needle electrodes.
Intrauterine Ultrasound (IUUS) Probe
The IUUS probe is a reusable component of the Sonata device that allows the user to locate fibroids from the inside of the uterus, docking to the underside of the handpiece via a magnetic socket.
F. Articulating tip
The three-position articulating tip features an imaging surface that adjusts from 0° to 45° or 60° using the articulation lever, providing a 114° field of view.
G. Articulation lever
The self-locking control arm pivots the articulating tip, press down to unlock, then move forward to adjust the angle.
H. Release latch
Secure and release the handpiece from the probe.
Treat Fibroids with Precision
SMART OS Technology: Setting Margins of Ablation in Real Time
The SMART OS™ guide technology overlays graphical indicators on the ultrasound image to help target fibroids and accurately position the introducer and needle electrodes, while the ablation zone and thermal safety border help protect adjacent tissue.
IUUS probe tip
Ablation zone
The red inner ellipse indicates the average region of tissue ablation.
Thermal safety border
The green outer ellipse indicates the distance at which tissue is safe from the potential of thermal damage.
SMART OS Guides Automatically Adjust
The size of the thermal safety border adjusts automatically in relationship to the ablation zone, controlling delivery of radiofrequency energy in real-time, to achieve the ablation size without the need for calculations. The Sonata system provides a 40-fold range from the smallest to the largest ablation volume.
Fibroids Indicated for Sonata RFA
The Sonata procedure can address a wide range of fibroid types and sizes, and can treat multiple fibroids during a single procedure. The Sonata System is designed to ablate, or partially ablate, all non-pedunculated fibroids.
Clinical Evidence
The Sonata procedure is an incisionless solution clinically proven to reduce fibroid symptoms, including heavy menstrual bleeding, with minimal down time.
50% of patients
returned to normal activity the next day.1
90% of patients
reported lighter periods within 3 months of their Sonata procedure.2
97% of patients
were satisfied with the Sonata procedure after 12 months.1
Hear from Sonata Patients
Hear what patients are saying about the Sonata procedure and browse our patient website which includes brochures, quizzes, and other resources, to help support your conversations with patients.
