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Hyperhidrosis treatment receives European marking approval

Miramar Labs announced that its miraDry System, previously approved by the FDA, has received CE mark approval in Europe for treating primary axillary hyperhidrosis.

“The physician and patient interest in Europe is arguably the strongest we’ve seen,” Steve Okland, Miramar Labs vice president of sales and marketing, Americas and Europe, said in a press release.

The FDA approved miraDry — which delivers energy noninvasively to destroy sweat glands in the underarm area — in 2011, according to the release. That approval was based on a trial of 120 patients at seven clinics who were followed for 1 year after treatment. In a follow-up study in Canada, patients sustained improvement in sweat reduction at 2 years posttreatment.

The 1-hour procedure is applied at a physicians’ office and typically requires two treatments for maximum results, according to Miramar Labs.