Gynesonics has received the US Food and Drug Administration (FDA) approval for its Sonata System 2.2 to treat symptomatic uterine fibroids.

Sonata System leverages radiofrequency energy to ablate fibroids within the uterine cavity, using real-time sonography guidance from the intrauterine ultrasound transducer.

It provides an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids, using a unique graphical user interface (SMART Guide).

The new generation Sonata System is said to deliver benefits, including a reduction in the ablation size setting by 20%, to treat fibroids in tight anatomical locations.

With the new software updates, surgeons are enabled to control all aspects of the ablation and can adjust ultrasound settings directly from the sterile field, eliminating OR staff.

Also, the intrauterine ultrasound reusable probe has been validated to be sterilised using the STERIS V-PRO family of low-temperature sterilisation systems.

Gynesonics engineering and advanced technologies vice president Jiayu Chen said: “This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field.

“These changes provide real benefit to the treating physicians and to a greater number of women seeking relief from their symptoms caused by fibroids.

“Additionally, the ability to make use of the widely available STERIS V-PRO family of low-temperature sterilisation systems and the notable engineering achievement of the new, reusable RF handpiece cable have cost benefits for the facilities and reduce the procedural waste.”

According to Gynesonics, the Sonata platform combines the first and only commercial intrauterine ultrasound system with an advanced radiofrequency ablation device.

It delivers treatment that is alternative to hysterectomy and myomectomy and can treat a wider range of fibroid types, sizes, and locations than hysteroscopic myomectomy.

Sonata System treats fibroids from within the uterus, where the procedure requires no incisions, and no tissue is surgically removed, and the uterus is retained, said the company.

The women’s healthcare company has obtained CE mark approval for the product, along with marketing approvals in the European Union (EU), the UK, and the US.

Gynesonics president and CEO Chris Owens said: “Gynesonics has a long and successful history of meaningful innovation, and changes that have real benefits to the healthcare system and to the patient.

“The new Sonata System 2.2 is a continuation of this commitment to innovation. The positive timing of this clearance coincides with the accelerated demand for Sonata.

“The new system provides greater features, ease-of-use and flexibility to physicians who wish to offer Sonata TFA to their patients and the millions of women who have been waiting for an option that does not require invasive, incisional surgery.”