FDA advisory panel recommends ultrasound fibroid therapy
An FDA advisory panel last week recommended the approval of a new treatment using ultrasound to break up fibrous clumps in the uterus as an alternative to removal of the uterus in a hysterectomy.
The ExAblate 2000 treatment is a product of InSightec, a unit of Tel-Aviv, Israel-based Elbit Medical Imaging. The final decision on approval will be made by the FDA.
InSightec said the advisory panel voted 8-5 for approval of the ExAblate, while the dissenters, according to the company, said the device was safe, but were not convinced of its efficacy.
The ExAblate procedure, cleared for use in Europe and Israel, uses MRI to pinpoint the non-cancerous tumors. Heat from ultrasound waves then is used to kill the fibroid tissue, which is flushed from the body naturally.
The ExAblate 2000 treatment is a product of InSightec, a unit of Tel-Aviv, Israel-based Elbit Medical Imaging. The final decision on approval will be made by the FDA.
InSightec said the advisory panel voted 8-5 for approval of the ExAblate, while the dissenters, according to the company, said the device was safe, but were not convinced of its efficacy.
The ExAblate procedure, cleared for use in Europe and Israel, uses MRI to pinpoint the non-cancerous tumors. Heat from ultrasound waves then is used to kill the fibroid tissue, which is flushed from the body naturally.