The device uses magnetic resonance (MR) images acquired during the procedure to deliver focused ultrasound to destruct brain tissue in a tiny area, which is expected to be responsible for causing tremors.
FDA said the patients treated with the ExAblate Neuro demonstrated around 50% improvement in their tremors and motor function three months after treatment compared to their baseline score.
In October last year, InSightec submitted a premarket approval application (PMA) to the FDA for ExAblate Neuro ultrasound device.
The PMA was submitted based on a two arm randomized controlled study, which included patients undergoing ExAblate MRgFUS treatment with patients undergoing a placebo treatment.
FDA’s Center for Devices and Radiological Health’s neurological and physical medicine devices director Dr Carlos Peña said: “Patients with essential tremor who have not seen improvement with medication now have a new treatment option that could help them to avoid more invasive surgical treatments.
“As with other treatments for essential tremor, this new device is not a cure but could help patients enjoy a better quality of life.”
According to the National Institute of Neurological Disorders and Stroke, several million Americans, usually those over age 40, are affected by the ET condition.
