MR-guided focused ultrasound developer InSightec has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its ExAblate Neuro device for treating essential tremor.
ExAblate Neuro uses high-intensity focused ultrasound (HIFU) to ablate target tissue and continuous MRI scanning to visualize anatomy, plan treatment, and monitor treatment outcomes, the company said. In the brain, it is used to perform a noninvasive thalamotomy to relieve tremor in patients with the condition.
InSightec's PMA submission includes data from a two-arm, randomized controlled trial that compared patients undergoing ExAblate MR-guided focused ultrasound treatment with patients undergoing a placebo treatment. (Patients in the placebo arm were later allowed to have ExAblate Neuro treatment.) The study was funded by the Focused Ultrasound Foundation, the U.S.-Israel Binational Industrial Research and Development (BIRD) group, and InSightec.
The PMA represents the first transcranial MR-guided focused ultrasound treatment being reviewed for FDA approval, according to InSightec.
