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FDA Approves New Ultrasound Treatment for Pain From Bone Metastases

Acoustic energy destroys pain-causing nerves (Oct. 22)

The FDA has approved ExAblate (InSightec Ltd.) magnetic resonance imaging (MRI)-guided, focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond to or cannot undergo radiation treatment for their pain. It was the second FDA approval for ExAblate, which was approved in 2004 as a noninvasive, outpatient therapy for uterine fibroids.

According to the American Cancer Society, more than two-thirds of metastatic breast and prostate cancers spread to the bones. Bone metastasis also occurs in up to 30% of metastatic lung, bladder, and thyroid cancers. Moreover, up to 30% of patients with bone metastases do not respond to radiation therapy or are unable to receive radiation for pain relief.

The new technique combines therapeutic acoustic ultrasound waves and continuous guidance and treatment monitoring with MRI. Physicians use the MRI to plan and guide the therapy and to monitor the treatment outcome. The focused ultrasound acoustic energy destroys the nerves that are causing the pain, resulting in rapid pain reduction.

The second FDA approval for ExAblate was based on the results of an international, multicenter, randomized clinical trial that compared patients with painful bone metastases undergoing palliative therapy with ExAblate with patients receiving placebo therapy. Patients who received treatment with ExAblate reported clinically significant pain relief and improved quality of life after 3 months of post-treatment follow-up.

ExAblate is currently the only FDA-approved MRI-guided ultrasound system for treating uterine fibroids and bone metastases related to pain management.

Source: InSightec Ltd., October 22, 2012.

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