FDA approves fibroid tx system.(News)

Negotiations with insurers are underway and some physicians' hopes for maximal efficacy are high now that the Food and Drug Admin-istration has approved the first noninvasive therapy for symptomatic uterine fibroids.

In a statement announcing the approval in late October 2004, the FDA said it expedited review of the ExAblate 2000 system--a device that ablates uterine fibroids using focused ultrasound under the guidance of magnetic resonance--because the device "offers significant advantages over existing treatments for uterine fibroids."

The FDA is requiring the manufacturer to conduct a 3-year postmarket study to better assess the long-term safety and effectiveness of the system.

Efficacy had been the primary concern of the members of the FDA advisory committee who voted against recommending the system in May 2004. The vote of the Obstetrics and Gynecology Devices Panel of the FDA's Medical Devices Advisory Committee was 8-5 in favor of approval.

The technology, known as magnetic resonance--guided focused ultrasound (MRgFUS), is novel in that it is the first time the two systems have been combined, and the first time that magnetic resonance has been used to monitor tissue temperature.

MRI is used not only to identify target regions for treatment, but also to provide a thermal map of the treatment area that enables physicians to confirm--in real time--the ultrasound's therapeutic effect.

The outpatient treatment involves repeated targeting and thermoablation of fibroid tissue while the patient, placed under conscious sedation, lies inside the MRI machine. In the pivotal study of the device, up to 100 pulses, or sonications, were delivered over a period of up to 3 hours.