Israel-based ultrasound technology provider InSightec has received the approval from Health Canada for its ExAblate system designed to treat uterine fibroids and pain palliation of bone metastases non-invasively.
The third generation ExAblate system uses high intensity focused ultrasound energy to destroy the targeted tissues while its MRI images help doctors in planning and guiding the therapy and monitoring the outcome.
The incision-less procedure requires no hospitalization and has a high safety profile that minimizes the risk of infection and complications whilst enabling patients to recover rapidly.
Health Canada’s approval was based on data published from clinical trials conducted in Canada, the US and Europe.
InSightec CEO Dr Kobi Vortman noted 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," Dr Vortman added.
Earlier in 2004, ExAblate received approval in the US and is claimed to be the only system to have both FDA and Health Canada’s clearances.
Globally, around 10,000 patients have been treated with ExAblate.