The US Food and Drug Administration (FDA) has granted approval to InSightec to initiate a multi-centre, double-blinded Phase III clinical study of its ExAblate Neuro device to treat essential tremor, a movement disorder.
Using MR-guided focused ultrasound (MRgFUS) therapy, the CE-marked device delivers high intensity ultrasound waves to destroy target tissue in the brain, while the patient lies in an MRI.
The device, which offers continuous visualisation, plan, guidance, monitoring and control of the treatment, also provides an incision-less treatment through the intact skull with no ionising radiation, according to the company.
The trial is based on the safety and initial efficacy results from 15 patient treated in an FDA feasibility trial, which was sponsored by the Focused Ultrasound Foundation.
Focused Ultrasound Foundation chairman dr Neal Kassell said the feasibility study validated the potential of focused ultrasound to treat essential tremor patients for whom currently available medications do not work and surgery is not an option.
"If the pivotal trial confirms early results, it could lead to the availability of a new, noninvasive treatment option," Kassell said.
The pivotal trial will enrol patients and randomise them to receive either ExAblate Neuro or no treatment.
The company, which is planning to conduct a one-year followup, is expecting to enrol the first patients in mid 2013.
InSightec said it will use the safety and effectiveness data provided from the Phase III study to support an FDA pre-marketing approval.
ExAblate Neuro is currently CE-marked for use in the treatment for tremor-dominant Parkinson's disease and neuropathic pain.