Insightec has received U.S. Food and Drug Administration (FDA) clearance for its focused ultrasound treatment to be used in patients with advanced Parkinson's disease.
The approval is for the use of Insightec's Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment for advanced Parkinson’s disease. The approval covers both the initial and subsequent staged procedures.
Exablate Neuro uses focused ultrasound guided by MRI to treat targeted areas in the pallidothalamic tract. The procedure is incisionless, does not require implanted hardware, and has a lower risk profile than traditional surgical interventions, Insightec said.
The platform has previously received FDA approval for unilateral treatment of medication-refractory essential tremor in 2016, tremor-dominant Parkinson’s disease in 2018, unilateral pallidotomy for Parkinson's related dyskinesia and motor symptoms in 2021, as well as for staged unilateral treatment for essential tremor patients for their second side following treatment of the first side in 2022.
Insightec plans a limited launch of the bilateral procedure in select centers this year. The firm added that its efforts to establish routine reimbursement pathways to ensure broader patient access are ongoing.
