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The FDA approved MRgFUS for treating essential tremor in July, 2016.

How the FDA Approved MRgFUS for Essential Tremor

When you shop for a new car, how do you decide which make and model to buy? It’s a pretty big investment, and today’s savvy car-buyers want to know the facts before they sign on the dotted line. To avoid time-consuming research, many consumers turn to independent sources like Consumer Reports. This organization has credibility because they not only do the research, they test the actual vehicles:

The cars team tests about 60 vehicles per year, driving them a total of about 900,000 miles. We also churn through reams of reliability and satisfaction survey data collected from our subscribers to supplement the analysis, evaluations, and ratings from the track1.

Patients are consumers who also make decisions based on someone else’s data collection and “road tests.” The millions of Americans who live with a condition called essential tremor (ET) must trust that their treatments are based on credible evidence. The first line of treatment is conventional medication such as a beta blockers or anticonvulsant drug. While 50-60% of patients experience improvement2, others find the medications less effective or they don’t like the side effects. There are also surgical approaches that can destroy or electronically stimulate a small center in the brain called the thalamus that controls involuntary movement, but “relatively few patients choose surgery because of perceived invasiveness from the burr holes [drilled in the skull] and intracerebral [implanted] electrodes.”3

There is a medical counterpart to groups like Consumer Reports. It is the U.S. Food and Drug Administration, a federal agency that holds watchdog responsibility for the safety and effectiveness of medical devices, drugs and other biological products. It is charged with “helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”4

Thanks to FDA approval, there is now an exciting alternative to ET drugs and invasive surgical procedures. In July, 2016 the FDA approved the first MRI-guided focused ultrasound (MRgFUS) device to treat ET. It is called Exablate Neuro, and it uses MRI scans before and during the procedure to plan and deliver focused ultrasound to destroy the area causing the tremors. It is 100% noninvasive because it does not need holes in the skull to accomplish the same task as surgery or implants.

Just like Consumer Reports, the FDA has a “show me” approach to approval. It includes clinical trials with humans as the ultimate “road test.” In the case of MRgFUS, numerous trials had been done (and are ongoing) and the FDA churned through all of the existing publications. In addition, the FDA required a “double-blind control trial involving 76 patients with essential tremor who had not responded to medication therapy. Fifty-six of the patients were randomly selected to receive the ExAblate Neuro treatment and 20 received a fake treatment.” 5The results showed that those who were treated with MRgFUS had about 50% improvement in their ET at 3 months. Together with past data, it was enough for the FDA to give MRgFUS a green light. Then, in keeping with its mission to help get the word out to the public, on July 11, 2016 the agency issued a press release announcing the approval and the scientific data behind it.

The Sperling Medical Group is pleased to offer MRgFUS for the treatment of ET. Our Center uses the FDA-approved device under the image guidance of our state-of-the-art 3T magnet. For more information, contact the Sperling Medical Group.

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1 http://www.consumerreports.org/cars-how-consumer-reports-tests-cars/
2Elias W, Lipsman N, Ondo W et al. Treatment of Medically Refractory Essential Tremor. NEJM. 2016;375:8, 792-793.
3Ibid.
4 https://www.fda.gov/AboutFDA/WhatWeDo/
5https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510595.htm

CATEGORY:
Essential Tremor

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