Miramar Labs has announced the 18 months of follow-up data from a study which evaluated the efficacy and safety of the miraDry system, a non-invasive technology designed to treat primary axillary hyperhidrosis (excessive underarm sweat).
The US Food & Drug Administration (FDA) has cleared miraDry, which works by delivering precisely controlled microwave energy non-invasively to the region where the sweat glands reside.
The miraDry system features a console, a hand piece and a bioTip, which is a sterile, single-patient use consumable which helps ensure safety and efficacy for the patient as well as protection of the equipment.
In the study, levels of underarm sweat were assessed by hyperhidrosis disease severity scale (HDSS) scores, gravimetric weight of sweat and the ten-question, validated dermatology life quality index (DLQI), a dermatology-specific quality-of-life scale.
Data demonstrated that patients treated with the miraDry system experienced about an 82% sweat reduction at 18-months post procedure, with patient satisfaction and efficacy of more than 90%.
Mark Lupin, director, founder and dermatologic surgery journal article co-author at Cosmedica in Victoria, British Columbia, said improvements made to the miraDry system and protocol over the earlier FDA approval study resulted in increased patient satisfaction and efficacy.
"Additionally, histology shows that the device's mechanism of action does in fact destroy sweat cells. Once destroyed, sweat glands do not regenerate. The miraDry procedure provides a lasting option for sweat sufferers enduring an often embarrassing condition," Lupin added.
Darrell Zoromski, president and chief executive officer at Miramar Labs, said the study data further validates the benefits of the miraDry procedure for those suffering from primary axillary hyperhidrosis.