US FDA clears Gynesonics’ platform for transcervical fibroid ablation

29 May 2020 (Last Updated May 29th, 2020 10:54)

Women’s healthcare company Gynesonics has received clearance from the US Food and Drug Administration (FDA) to commercially launch its Sonata System 2.1 for transcervical fibroid ablation (TFA).

US FDA clears Gynesonics’ platform for transcervical fibroid ablation
Gynesonics platform integrates intrauterine ultrasound system with the company’s proprietary advanced radiofrequency ablation device. Credit: James Heilman, MD.

Women’s healthcare company Gynesonics has received clearance from the US Food and Drug Administration (FDA) to commercially launch its Sonata System 2.1 for transcervical fibroid ablation (TFA).

The platform integrates intrauterine ultrasound system with the company’s advanced radiofrequency ablation device to offer incision-free transcervical treatment for symptomatic uterine fibroids.

The new improvements in Sonata 2.1 include a new integrated treatment device design that allows all procedure steps to be performed on the sterile field and a smaller, more ergonomic radio-frequency ablation handpiece with better controls.

Furthermore, it offers an advanced graphical user interface with new SMART technology procedural cues. The new design is also said to considerably improve the manufacturability of the device.

Gynesonics president and CEO Christopher Owens said: “FDA clearance for our advanced Sonata System 2.1 is a noteworthy achievement. The feedback from European physicians on the improved system design and performance during the early 2020 launch in Europe is positive. This contributed to a significant increase in procedure volumes.

“We look forward to introducing the technology to the US market and others around the globe. This highlights Gynesonics’ commitment to consistently deliver breakthrough advances for women’s health while continuing to demonstrate our clinical significance through published peer-reviewed evidence.”

The company said that the new system has been implemented earlier this year at SpitalOberengadin – Schweiz. The system has shown improved efficiency and patient outcomes during fibroid treatments.

It is estimated that more than one million TFA procedures take place around the world every year.

Gynesonics anticipates approximately $4bn global market opportunity for the Sonata System, including a market opportunity of more than $1bn in the US alone.

In 2019 November, the company launched Sonata 2 System in the US and Europe.