Focused-ultrasound developer InSightec has received clearance from the U.S. Food and Drug Administration (FDA) for its ExAblate MRI-guided focused-ultrasound system to treat pain from bone metastases in patients who do not respond to or cannot undergo radiation therapy.
This is the second FDA clearance the company has received for the system, which has been used since 2004 as a noninvasive outpatient therapy for uterine fibroids. The new approval was based on the results of an international, multicenter, randomized trial comparing patients with painful bone metastases receiving palliative therapy with ExAblate to a similar group receiving placebo therapy, InSightec said.
Patients who underwent the ExAblate therapy reported significant pain relief and improved quality of life at 90 days after treatment. More than 15 centers in Canada, Italy, Israel, Russia, and the U.S. participated in the clinical trial.
A multicenter postmarketing study of 70 U.S. patients who suffer from painful bone metastases will be conducted in the near future. InSightec, a privately held company owned by technology firm Elbit Imaging, GE Healthcare, and venture capital firm MediTech Advisors, said it will also establish a commercial registry to collect data about patients undergoing ExAblate therapy for the palliation of painful bone metastases.
ExAblate has already received CE Mark approval for uterine fibroids, adenomyosis, and bone metastases, InSightec said.
