UPDATED July 12, 2016, with comment from study investigators, Insightec CEO.
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-market 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.
“I am confident that we have arrived at a tipping point for non-invasive medical treatment. Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body. With Exablate Neuro, Insightec expands its Exablate product line with a system that signifies a new era for functional neurosurgery,” chairman & CEO Dr. Maurice Ferré said in a press release. Ferré led Mako Surgical until its $1.7 billion acquisition by Stryker (NYSE:SYK).
“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor. Finding the most effective way to manage tremor symptoms is crucial for patients. The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing,” added principal investigator Dr. Jeffrey Elias of the University of Virginia.
“This newly FDA-approved device provides a new treatment option without some of the complications associated with surgery to offer patients with essential tremor. Furthermore, it holds promise for a range of neurosurgical procedures,” study investigator Dr. Andres Lozano, of Toronto Western Hospital, said in a prepared statement.
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.