InSightec nets FDA approval for bone pain ultrasound therapy

The FDA has approved InSightec's ExAblate MRI guided focused ultrasound for treatment of painful bone metastases in patients who are not candidates for or refuse to undergo radiation treatment.

This is the second FDA approval for ExAblate, which received FDA approval in 2004 as a non-invasive, outpatient therapy for uterine fibroids. GE Healthcare is a minority shareholder of Insightec and is a distributor of ExAblate in many countries.

InSightec’s ExAblate system is exclusively compatible with GE Healthcare’s normal and wide-bore MR systems, including Signa HDxt 1.5T, Signa HDxt 3.0T, Optima MR450 & 450w and Discovery MR750 & 750w. It combines therapeutic acoustic ultrasound waves with guidance and treatment monitoring by MRI. This combination of technologies is called Magnetic Resonance guided Focused Ultrasound Therapy (MRgFUS). Physicians use the MRI to plan and guide the therapy and monitor treatment outcome. The focused ultrasound acoustic energy can destroy the nerves causing the pain from bone metastases, resulting in rapid reduction in pain, according to Insightec.

ExAblate also has received European CE marking for uterine fibroids, bone metastases and adenomyosis. ExAblate will be co-marketed by GE as InSightec’s distributor.