Insightec said today it submitted a premarket approval application to the FDA for its Exablate Neuro device seeking an indication to treat essential tremors.
The Exablate Neuro uses high intensity focused ultrasound to thermally ablate targeted tissue and uses continuous magnetic resonance imaging to visualize anatomy to plan and monitor treatments and outcomes.
The MR-guided focused ultrasound procedure can be performed non-invasively through an intact skull to relieve tremors in patients with essential tremors, the Israel-based company said.
“This is another major achievement, our third clinical indication submitted for FDA approval and the first PMA for Neurosurgery. This represents our continued commitment to transform MRgFUS from an investigational technology to a standard of care treatment option for neurological patients,” CEO Dr. Kobi Vortman said in prepared remarks.
The PMA submission was based on a randomized controlled trial of the device, the company said.
“This is the 1st transcranial MRgFUS treatment being reviewed for FDA approval. It follows years of development with significant technological breakthroughs. We believe that this is only the starting point in many neurosurgery developments to come our way in the coming future,” R&D veep Eyal Zadicario said in a press release.
Earlier this month, Insightec said it won expanded FDA premarket approval for its next generation Exablate system used to treat symptomatic uterine fibroids for patients who wish to retain their uterus and fertility.
The approval was based upon documented clinical data from 118 patients who became pregnant after receiving treatment with the Exablate device, Insightec said.