InSightec has received approval from the Chinese Food and Drug Administration (CFDA) for its ExAblate system designed to treat uterine fibroids non-invasively.
This system uses high intensity focused ultrasound energy to destroy the fibroids while its MRI images help doctors in planning and guiding the therapy and monitoring the outcome.
The incision-less procedure requires no hospitalization and has a high safety profile that minimizes the risk of infection and complications whilst enabling patients to recover rapidly.
InSightec CEO Dr Kobi Vortman 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."
Earlier in 2004, ExAblate received approval in the US and is claimed to be the only system to have both FDA and CFDA clearances.
The CFDA approval was based on a data published from clinical trials conducted at Peking Union Medical College Hospital and China Medical University First Hospital.
Dr Jin Zhengyu, the lead investigator noted the patients who underwent ExAblate treatment in the clinical study were able to return home within few hours and to normal life within one or two days.
"It is a safe and effective way to treat women with symptomatic fibroids and should be offered as a non-invasive treatment option," Dr Zhengyu added.
