FDA approve ExAblate (InsighTec) to treat Pain from Bone Metastases

The FDA has approved ExAblate MRI-guided focused ultrasound, from InsighTec, as a therapy to treat Pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. The ExAblate system integrates magnetic resonance imaging and high intensity focused ultrasound. FDA approval was based on the results of an international, multi-center, randomized clinical study comparing patients with painful bone metastases undergoing palliative therapy with ExAblate to a similar group undergoing a placebo therapy. Patients who underwent the ExAblate therapy reported clinically significant pain relief and improvement of quality-of-life during follow-up three months after treatment. Over 15 centers participated in the clinical trial. It was approved in 2004 as a non-invasive, outpatient, therapy for uterine fibroids.