InSightec of Tirat Carmel, Israel received FDA regulatory clearance for its ExAblate MRI-guided focused ultrasound system to be used to treat pain in patients with bone metastases that are poor candidate for radiation pain treatment. The system has been approved in the U.S. for the last eight years as a therapy option for uterine fibroids.
The system allows physicians to create a plan for ultrasound treatment and use real-time MRI imaging to monitor and guide each therapy session. A previous study has demonstrated significant pain reduction for cancer patients with bone metastases who received ExAblate treatment and the company plans to conduct another on 70 patients to collect more data.
From the announcement:
“The recent FDA approval of ExAblate for pain palliation will offer new options for cancer patients with crippling bone pain who are seeking pain-management options and are no longer eligible for radiation treatment,” said Dr. Kobi Vortman, President and CEO of InSightec. “This is the second FDA approval for the ExAblate technology and represents a significant milestone in our quest to expand the applications for this innovative, non-invasive therapy. It also demonstrates our continued commitment to bringing ExAblate MRI-guided focused ultrasound into broad clinical use and improving our patients’ quality of life.”
The second FDA approval for ExAblate 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 including Fox Chase Cancer Canter, Stanford University, UCSD, UVA, Moffitt, and Brigham and Women’s Hospital in the US as well as University of Toronto, La Sapienza University in Rome, Sheba and Rambam Medical Centers in Israel, Petrov Research Institute of Oncology and Rostov Medical University in Russia.
ExAblate is the only FDA-approved MRI-guided focused ultrasound system for treating uterine fibroids and bone metastases related pain management. It has also received European CE marking for uterine fibroids, bone metastases, and adenomyosis. Twenty hospitals in Europe and Asia-Pacific offer ExAblate as a palliative therapy for bone metastases.
Flashbacks: MRI Guided Focused Ultrasound for Noninvasive Treatment of Prostate Cancer; FDA Expands Indication for Insightec’s Uterine Fibroid System; Noninvasive Palliation of Pain of Bone Mets; ExAblate Making Waves in US; ExAblate 2000