InSightec, Ltd. announced today that its ExAblate MRI-guided Focused Ultrasound system has received FDA approval to treat pain associated with bone metastasis. This is the second FDA-approved use of the ExAblate, which gained regulatory approval in 2004 for the treatment of symptomatic treat uterine fibroids.
In conjuction with a press release, the company issued multiple videos and links to background materials. Links to all are provided below.Press Release: FDA Approves New Non-Invasive, Non-Ionizing Radiation Therapy to Treat Pain from Bone Metastases ExAblate® MRI-guided Focused Ultrasound is effective in reducing pain from bone metastases in patients who could not undergo radiation therapy; Patients reported significant improvement in well-being, function, and reduction in medication use
TIRAT CARMEL, Israel October 22, PR Newswire – InSightec Ltd, the leader in magnetic resonance imaging (MRI)-guided Focused Ultrasound therapy, announced that the U.S. Food and Drug Administration (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, which has been used widely since it was approved in 2004 as a non-invasive, outpatient, therapy for uterine fibroids. READ FULL RELEASEAdditional information:
Patient story treated by ExAblate for pain reduction caused by bone mets in Philadelphia, as told by Dr. Joshua Meyer
Case story of patient treated by ExAblate for pain reduction of bone mets in Massachusets, as told by Dr. Mark Hurwitz
An overview of ExAblate for bone:
Doctors explaining the FDA clinical studies:
An overview of InSightec, it's technology and research:
TEDMED: Yoav Medan, October 2011.