EXABLATE RECEIVES APPROVAL OF HEALTH CANADA
ExAblate receives Approval of Health Canada for the Treatment of Uterine Fibroids and Pain Palliation of Bone Metastases.
Third generation ExAblate system, using non-invasive MR guided Focused Ultrasound (MRgFUS) now available for Canadian patients.
Tirat Carmel, Israel (August 20, 2013). INSIGHTEC Ltd, the leader in MR guided Focused Ultrasound therapy, announced that its ExAblate system received approval of 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-ionizing radiation, the treatment allows patients a rapid recovery while minimizing 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.
Dr. Kobi Vortman, CEO and founder of INSIGHTEC said, "Health Canada’s approval is another vote of confidence in ExAblate’s high safety profile and excellent outcomes. It once again highlights INSIGHTEC’s firm commitment to expand clinical indications in gynecology as well as in oncology and neurosurgery."