InSightec, an Israel- based provider of MR guided focused ultrasound therapy, has obtained the approval from Health Canada for its ExAblate system designed to treat both uterine fibroids and pain palliation of bone metastases non-invasively.
The third generation ExAblate system utilises both high-intensity focused ultrasound waves and continuous MRI guidance and monitoring in the treatment of uterine fibroids and pain palliation of bone metastases.
While the ultrasound energy is used to heat and destroy the targeted tissues, its magnetic resonance imaging (MRI) images help doctors in planning and administering an appropriate therapy and monitoring the treatment outcome.
ExAblate provides a higher safety profile to patients as it is incisionless and the treatment is usually completed in a single session with low risk of infection and complications.
The patient's quality of life is also substantially improved as it minimises morbidity and trauma associated with the treatment and promises a swifter recovery.
The Health Canada 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.
The system, which received the US FDA approval in 2004, is claimed to be the only MR-guided ultrasound system to have secured both US FDA and Health Canada's clearances.
In July 2013, the company received Chinese Food and Drug Administration (CFDA) for non-invasive treatment of uterine fibroids and an extended European CE Mark for its ExAblate 2000 and 2100, as well as the ExAblate 2100 conformal bone system.
Globally, around 10,000 patients have been treated with the ExAblate system.