The US Food and Drug Administration (FDA) has approved Gynesonics’ next-generation Sonata System 2.2 for radiofrequency ablation of fibroids.
The Sonata technology platform integrates a commercial intrauterine ultrasound system with an advanced radiofrequency ablation device to provide an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids.
Gynesonics noted that the Sonata Treatment is said to be an alternative to hysterectomy and myomectomy. It also has the ability to treat a broad range of fibroid types, sizes and locations.
The Sonata System 2.2 offers a 20% reduction in the smallest ablation size setting, which increases the ability to treat fibroids in tighter anatomical locations.
With the new software developments, surgeons can use the handpiece to control all aspects of ablation and adjust the ultrasound settings directly from the sterile field.
The novel intrauterine ultrasound reusable probe is also now authorised to be sterilised using the family of STERIS V-PRO low-temperature sterilisation systems.
Additionally, the Sonata System 2.2 includes a new reusable cable.
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.”
In May last year, the company received FDA clearance to market its Sonata System 2.1 for transcervical fibroid ablation.