Focused Ultrasound Therapy
The FDA has approved Profound Medical’s Sonalleve device for the treatment of patients with Osteoid Osteoma. For more information on treatment site locations, please see Profound Medical’s website.
Focused ultrasound is an early-stage, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with osteoid osteoma. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.
How it Works
Where the beams converge, focused ultrasound produces precise ablation (thermal destruction of tissue) enabling osteoid osteoma to be treated without surgery.
The primary options for treatment of osteoid osteoma include pain medications, but some cases require invasive surgery.
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary.
A study has opened at the University of California in San Francisco (UCSF) and Stanford University, which is comparing MR-guided focused ultrasound treatment for osteoid osteoma to radiofrequency ablation.
A clinical trial at Children’s National in Washington D.C. is treating patients with painful osteoid osteoma.
A clinical trial in France is treating patients with bone metastatic lesions or with osteoid osteoma.
A registry, funded in part by the Foundation, has begun and will enroll more patients at additional sites worldwide. For more information, contact Simal Goman at 416-813-6456.
For a full list of osteoid osteoma clinical trials, please see here.
Regulatory Approval and Reimbursement
The Profound Medical Sonalleve is FDA approved for treatment of osteoid osteoma in the US. Chongqing Haifu Medical Technology is approved for osteoid osteoma in Europe, Russia and China. The Insightec ExAblate Neuro is approved for treating this condition in Europe.
To date, focused ultrasound is not widely reimbursed by medical insurers for treatment of osteoid osteoma.
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Click here for additional references from PubMed.