EXABLATE RECEIVES APPROVAL OF CHINESE FOOD AND DRUG ADMINISTRATION
INSIGHTEC Ltd, the leader in MR guided Focused Ultrasound therapy, announced that its Exablate system received approval of the Chinese Food and Drug Administration (CFDA) for non-invasive treatment of uterine fibroids.
Uterine fibroids are benign tumors that grow in the uterus. 20-50% of women of childbearing age suffer from uterine fibroids. Hysterectomy, surgical removal of the uterus, is the most common form of treatment.
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.
Exablate benefits are that it is incisionless, requires no hospitalization, has a high safety profile with low risk of infection and complications, and rapid recovery.
Exablate received approval by the United States FDA in 2004 and is the only MR guided Focused Ultrasound system to have both FDA and CFDA approval. Thousands of women have been treated with the system around the world.
Dr. 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 Prof. Jin Zhengyu, the lead investigator.