FDA approves ExAblate technology to treat late stage bone pain

According to a media release issued yesterday, The U. S. Food and Drug Administration has approved a form of MRI-guided, focused ultrasound therapy for the treatment of pain associated with metastatic cancer to bone. Since bone metastases and associated bone pain are common consequences of late stage, metastatic prostate cancer, this approval is clearly of importance to the prostate cancer community.

The media release issued by InSightec, an Israel-based medical technology company, states that its ExAblate® MRI-guided, focused ultrasound technology is indicated to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. Results from an international, multi-center, randomized clinical trial conducted to data have apparently shown that “ExAblate therapy significantly reduces pain caused by bone metastases” and that “Patients also reported lasting improvement in well being and function, along with a decrease in the need for medication.”

InSightec’s ExAblate system uses a combination of therapeutic acoustic ultrasound waves with continuous guidance and treatment monitoring with an MRI. Clinicians use the MRI to plan and guide the focused ultrasound therapy and monitor treatment outcome. The ultrasound energy can destroy the nerves causing the pain, leading to a significant reduction in pain for many patients. Apparently some 20 specialized centers in Europe are already able to provide this type of MRI-guided, focused ultrasound as a palliative therapy for bone metastases. It is not yet clear how many centers in the USA or elsewhere may have access to this technology.

As a condition of the approval of this technology in the USA, it seems that the FDA has asked InSightec to carry out a multi-center post-marketing study of 70 US patients with painful bone metastases and to establish a registry to collect data about patients undergoing ExAblate therapy among other, similar patients

2 Responses

  1. What does this approval mean for the related HIFU prostate cancer treatment, either focal or bifocal treatment?

  2. This approval means absolutely nothing with regard to the use of HIFU as a first- or a second-line treatment for localized prostate cancer. This approval is limited exclusively to the use of a particular form of focused ultrasound to palliate pain in men with bone mets.

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