On 27 November 2020, the US Food and Drug Administration (FDA) approved the Sonalleve MR-HIFU system (Profound Medical Inc.) for the treatment of osteoid osteoma in the extremities. <\/p>\n
MR-guided High Intensity Focused Ultrasound (MR-HIFU) treatment is an image guided technique combining high intensity focused ultrasound ablation with real time monitoring of temperature change during the sonication. <\/p>\n
The clinical results support the probable benefit of Sonalleve MR-HIFU system for the ablation of painful osteoid osteoma. Efficacy was evaluated in a study of nine patients treated with MR-HIFU, without technical difficulties or serious adverse events. There was a statistically significant decrease in their pain scores within 4 weeks of treatment. No pain medication usage was achieved in 8 of 9 patients after 4 weeks. <\/p>\n
The device should not be used under certain conditions. For full information including warnings and precautions, view the Summary of Safety and Probable Benefit Document for the Sonalleve MR-HIFU system that is available here<\/a>. <\/p>\n Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System. <\/p>\n For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA\u2019s Oncology Center of Excellence<\/a> Project Facilitate<\/a>.<\/p>\n