FDA Approves MRI-Guided Focused Ultrasound Therapy To Treat Pain from Bone Metastases

FDA approval confirms that ExAblate® MRI-guided Focused Ultrasound is effective in reducing pain from bone metastases in patients who could not undergo radiation therapy.

In short

Israeli image-guided ultrasound company InSightec Ltd, has announced that the U.S. FDA has approved its ExAblate® MRI-guided focused system for use in treating pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain.

Background

Bone metastases occur when cancer cells break away from their primary site and spread to other parts of the body. According to the American Cancer Society, more than two-thirds of breast and prostate cancers that metastasize spread to the bones and this also occurs in up to 30% of metastatic lung, bladder and thyroid cancers. Up to thirty percent of patients with bone metastases either do not respond to radiation therapy or will be unable to undergo radiation for pain relief.

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.
This approval, ExAblate’s second, was based on the results of an international, multi-centre, randomised 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.
Investigator comments 

“Pain is the most common and severe symptom of bone metastases, often causing significant physical and emotional discomfort with a large impact on enjoyment of life,” says Mark Hurwitz, M.D., principal investigator of the international, multi-centre, randomised study that formed the basis of InSightec’s Pre-Market Approval (PMA) application with the FDA. “Pain palliation by ExAblate can dramatically improve the quality of life for cancer patients with bone metastases. Results from the clinical study showed that ExAblate therapy significantly reduces pain caused by bone metastases. Patients also reported lasting improvement in well being and function, along with a decrease in the need for medication.”

Company comments

“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.”

Regulatory status 

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.

Source: InSightec Ltd.

published: October 24, 2012 in: Approval/Clearance, Imaging, Oncology, Technology

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