InSightec Ltd, a majority-owned subsidiary of Elbit Medical Imaging Ltd, reported that the Obstetrics and Gynecology Devices Panel of the US Food and Drug Administration (FDA) has recommended the company's ExAblate 2000 System for the non-invasive treatment of uterine fibroids for approval, with post-approval conditions.
The ExAblate System is the first Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) system to be reviewed by the panel and recommended for FDA approval, the company claims.
The ExAblate System is intended to provide a non-invasive alternative to current treatments for symptomatic uterine fibroids, which include hysterectomy, myomectomy, uterine artery embolization, and drug therapy. Uterine fibroids are the most common reason for surgery among women of reproductive age, after caesarean section.
Dr Jacob Vortman, president and CEO of InSightec, said, "We are pleased with the recommendation for approval and look forward to working closely with the FDA on the specific conditions for approval. Although the concept of focused ultrasound has been researched for over 60 years, this is the first time an implementation of this technology has been recommended for FDA approval."
Post-approval conditions recommended by the FDA panel were related to the development of training material and labeling.