InSightec announced that its Exablate system received approval from the Chinese Food and Drug Administration (CFDA) for magnetic resonance-guided focused ultrasound treatment of uterine fibroids.
Exablate combines high intensity focused ultrasound waves and continuous MRI guidance and monitoring. The focused ultrasound energy is used to ablate or destroy the fibroids while the MRI images are used to plan and guide the therapy and monitor treatment outcome.
The benefits of being treated by magnetic resonance-guided focused ultrasound are that the procedure is incisionless, requires no hospitalisation, has a high safety profile with low risk of infection and complications, and rapid recovery.
Exablate received approval by the US Food and Drug Administration (FDA) in 2004 and is the only magnetic resonance-guided focused ultrasound system to have both the FDA and CFDA approval and has been used extensively across the world.
Kobi Vortman, CEO and founder of InSightec said, “We are extremely proud to have received CFDA approval for Exablate which is another vote of confidence in Exablate’s high safety profile and excellent outcomes.”
The CFDA approval was based on data published from clinical trials conducted at Peking Union Medical College Hospital and China Medical University First Hospital.
“In our clinical study we found that patients who underwent Exablate treatment were able to return home within few hours and to normal life within one or two day. It is a safe and effective way to treat women with symptomatic fibroids and should be offered as a non-invasive treatment option.” said Jin Zhengyu, the lead investigator.