InSightec Ltd announced that the FDA has approved ExAblate MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. This is the second FDA approval for ExAblate since it was approved in 2004 as a noninvasive outpatient therapy for uterine fibroids.
Improved Quality of Life
ExAblate combines therapeutic acoustic ultrasound waves and continuous guidance and treatment monitoring with an MRI. Physicians use the MRI to plan and guide the therapy and monitor treatment outcome. The focused ultrasound acoustic energy destroys the nerves causing the pain, resulting in rapid reduction in pain.
The second FDA approval for ExAblate was based on the results of an international, multicenter, 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 including Fox Chase Cancer Canter, Stanford University, UCSD, UVA, Moffitt Cancer Center, and Brigham and Women’s Hospital in the United States as well as University of Toronto, La Sapienza University in Rome, Sheba and Rambam Medical Centers in Israel, and Petrov Research Institute of Oncology and Rostov Medical University in Russia. ■