FDA approves Insightec’s Exablate Neuro focused ultrasound device

The FDA said today that it approved the Exablate Neuro device made by Insightec for treating essential tremor in patients who don’t respond to drug therapy.

The Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.

Essential tremor can be treated with beta blockers or anti-convulsant drugs, but some patients don’t respond to drug treatment, the federal safety watchdog said. A surgical treatment called thalamotomy or deep-brain stimulation can also be used to destroy portions of the thalamus, which controls some involuntary movements. Insightec applied for pre-,arket approval for the Exablate Neuro treatment in October 2015.

“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,” Carlos Peña, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “As with other treatments for essential tremor, this new device is not a cure but could help patients enjoy a better quality of life.”

The FDA said a 76-patient, double-blinded trial found that patients treated with Exablate Neuro showed a nearly 50% improvement in tremor and motor function after 3 months; patients in the sham control arm showed no improvement and symptoms worsened for some patients (subjects in the sham arm were allowed to cross over to the treatment arm after 3 months, the agency said). The improvement in the treatment arm was 40% at 12 months, the FDA said.

Exablate Neuro won a nod from Health Canada in May.

“Insightec is at the forefront of the global shift towards non-invasive procedures. Ultimately, our goal is to transform medical practices as we know them today and to improve patient outcomes, reduce morbidity and trauma while reducing costs. Health Canada’s regulatory approval of our Exablate Neuro technology is an important milestone in our path to fulfilling our mission,” new chairman & CEO Dr. Maurice Ferré said at the time. Ferré led Mako Surgical until its $1.7 billion acquisition by Stryker (NYSE:SYK).

In January Insightec pulled down a $22 million funding round and tapped Ferré, with former CEO Kobi Vortman stepping down and taking a seat on the board.

High-intensity focused ultrasound drew widespread attention in March after bestselling author John Grisham highlighted the therapy in “The Tumor,” is a fictional account of a 35-year-old man with brain cancer who, a decade into the future, is treated with focused ultrasound.

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