InSightec announced that its Exablate system received approval from Health Canada for MRgFUS treatment of uterine fibroids and for pain palliation of bone metastases.
Exablate combines high intensity focused ultrasound waves and continuous MRI guidance and monitoring. The focused ultrasound energy is used to heat and destroy the targeted tissue while the MR images are used to guide the energy beam and monitor treatment outcome. Exablate’s main benefits are that in a single session with this non-ionising radiation, the treatment allows patients a rapid recovery while minimising morbidity and trauma with a high safety profile, thus improving patients’ quality of life.
Health Canada’s approval was based on data published from clinical trials conducted in Canada, the USA and Europe. Exablate received the first approval by the United States FDA in 2004 and is the only MR-guided Focused Ultrasound system to have both FDA and Health Canada’s approval. Ten thousand patients globally have already been treated with Exablate.