US-based women’s healthcare firm Gynesonics has secured CE Mark approval for its next-generation VizAblate System designed for treatment of symptomatic uterine fibroids.
The CE Mark allows the company to market its proprietary VizAblate System across the European Union (EU).
Gynesonics president and CEO Christopher Owens said: "This regulatory clearance is an important milestone for the organisation.
"We look forward to sharing additional clinical data while moving forward with our commercialisation strategy to provide millions of women with a novel and less-invasive solution to treat their symptomatic uterine fibroids."
VizAblate integrates ultrasound image guidance and radiofrequency ablation into a single handheld device.
The device uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance.
The company said that users can visually target specific fibroids and optimise ablations within them with the new VizAblate device and software.
VizAblate’s transcervical access is simple, is associated with short procedure times, requires minimal in-procedure assistance, and is incision-free.
The VizAblate system features proprietary intrauterine ultrasound probe that provides high-resolution, clear image and it does not violate the uterine serosa or peritoneal cavity and is a distinct alternative to power morcellation procedures.
According to the company, physicians familiar with the previous VizAblate device are also looking forward to the deployment of the next-generation design.
Vrije Universiteit Medisch Centrum gynecologist Hans Brölmann said: "The imaging is clear and the ease of use will provide gynecologists with an exciting new fibroid treatment that delivers short procedure times."