January 25, 2012 — InSightec Ltd. announced that it has submitted a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for its ExAblate treatment of pain palliation of bone metastases. ExAblate uses magnetic resonance guided focused ultrasound (MRgFUS) to treat the pain caused by bone metastases non-invasively and without ionizing radiation.

Over 60 percent of cancer patients suffer from painful bone metastases. Of these, 30 percent will not respond to radiation therapy. ExAblate was investigated as an option for these patients. The PMA submission was based on a two-arm randomized controlled trial comparing patients undergoing ExAblate's MR guided focused ultrasound for palliation of painful bone metastases with patients undergoing no treatment.

Patients who had no response to the sham treatment were later allowed to undergo an ExAblate treatment. The FDA also granted an expedited review process for the PMA submission.

ExAblate combines high intensity focused ultrasound to thermally ablate tumors and continuous MRI to visualize the anatomy, plan treatment and monitor treatment outcomes in real time.

ExAblate is the only MRgFUS system with FDA approval, granted in 2004 for uterine fibroids. It also received European CE marking for uterine fibroids, bone metastases, and adenomyosis. Clinical trials are ongoing for brain disorders, including essential tremor and Parkinson's disease, and prostate cancer.

For more information: www.insightec.com, www.bone-pain-palliation.co.uk/

Related Content

News | ASTRO

October 27, 2021 — The time required to secure prior authorization approvals for radiation therapy treatments equates to ...

Time October 27, 2021
arrow
News | Radiation Oncology

October 25, 2021 — A new study shows that system-level changes to the way cancer care is delivered can also eliminate ...

Time October 25, 2021
arrow
News | Prostate Cancer

October 25, 2021 — A new meta-analysis finds that a genetic biomarker test accurately predicts how men with high-risk ...

Time October 25, 2021
arrow
News | Prostate Cancer

October 25, 2021 — Using fewer—but higher—doses of radiation to treat men with prostate cancer who had their prostates ...

Time October 25, 2021
arrow
News | Stereotactic Body Radiation Therapy (SBRT)

October 24, 2021 — High-dose radiation therapy can be used to lengthen progression-free survival for people with ...

Time October 24, 2021
arrow
News | Radiation Therapy

October 24, 2021 — People with liver cancer awaiting transplantation could benefit from non-invasive radiation ...

Time October 24, 2021
arrow
News | Radiation Therapy

October 22, 2021 — At this year’s ASTRO 2021 event, GE Healthcare will showcase over 15 innovative multi-modality ...

Time October 22, 2021
arrow
News | Proton Therapy

October 22, 2021 — RaySearch Laboratories AB and Mevion Medical Systems, two companies that are leading the field of ...

Time October 22, 2021
arrow
News | Intensity Modulated Radiation Therapy (IMRT)

October 22, 2021 — RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a ...

Time October 22, 2021
arrow
News | Oncology Information Management Systems (OIMS)

October 22, 2021 — The latest versions of RayStation (11A) and RayCare (5A) were released in May 2021. A new feature in ...

Time October 22, 2021
arrow
Subscribe Now