Special report: Therapeutic ultrasound heats up

by Brendon Nafziger, DOTmed News Associate Editor | July 12, 2013
From the July 2013 issue of HealthCare Business News magazine

Essential tremor is a neurodegenerative disease characterized by an unpleasant rhythmic shaking of the hands or other limbs. Zadicario says it’s the most common movement tremor worldwide. About 10 million people suffer from it in the United States, making it nearly eight times more prevalent than Parkinson’s disease, according to the International Essential Tremor Foundation.

Sadly, about 30 percent of cases don’t respond to medication, Zadicario says. For them, the treatment of choice is usually deep brain stimulation, where a pacemaker-type device is surgically implanted, and which sends brief jolts to the brain to control tremors. But Zadicario believes there’s a market for a surgery-free alternative.

“There is a very significant interest from the essential tremor patient society for non-invasive treatment,” he says.

Enter ExAblate Neuro, the brain-treatment version of InSightec’s MR-HIFU device. In late April, InSightec and University of Virginia researchers, led by Dr. Jeffery Elias, presented results of a phase I feasibly study using the device to treat essential tremor at the American Association of Neurological Surgeons annual event in New Orleans. In the trial, researchers used the ExAblate Neuro to zap tissue in the thalamus, particularly around the Vim nucleus, which is implicated in the tremors.

Elias and colleagues said after the therapy, the 15 patients in the trial experienced an average 67 percent decrease in symptoms, according to a Richmond Times-Dispatch write-up.

“We reduced the amount of tremor in the dominant hand fairly substantially,” Elias told the paper. “That led to a very significant improvement in quality of life.”

So far, though, the data are only preliminary. As part of the full FDA application process, Zadicario says they’ll launch a multi-center pivotal study with around 70 patients at five sites in the U.S., and up to eight worldwide. Overall, Zadicario expects a three-year commercialization process.

But non-Americans already have access to the treatment. The ExAblate Neuro was approved for sale in the European Union on December 27 in Europe, with two sites in Switzerland offering treatment now, Zadicario says.

Breast cancer

One potential application of MR-HIFU, and one of possibly the greatest interest both to the vendors and to clinicians, is cancer treatment. Both InSightec and Philips have clinical trials underway investigating how their devices fare against a variety of cancers. Last year, Philips says it launched a feasibility pilot trial on breast cancer treatments with 10 patients. For the trial, the company says they built a dedicated version of the Sonalleve to accommodate the anatomy of the breast.

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