Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis

Exclusion Criteria

• •Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy.
• •Subject has hyperhidrosis on the trunk or chest.
• •Subject has evidence of active infection.
• •Prior endoscopic thoracic sympathectomy, liposuction or other surgery for axillary hyperhidrosis.
• •Axillary injection of botulinum toxin within one year preceding the miraDry treatment.
• •Oral anticholinergic medication use (e.g., Robinul) or cholomimetic medication use within the last 4 weeks or planned use during the study's follow up phase.
• •Subject is a prisoner or under incarceration.
• •Currently participating in or recently participated in another clinical trial (within the last 30 days).
• •History of or current neurologic deficit in the treatment limb.
• •Known resistance to or history of difficulty with local anesthesia (lidocaine with epinephrine).
• •History of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) subjects with a history of successfully treated cancer that have been disease-free for five years.
• •Injury in the treatment area, shoulder or limb, which, in the opinion of the physician would render this subject an unacceptable candidate for DTS treatment (e.g., prior surgical repair, injury of the shoulder requiring physical therapy).
• •Subject has a pacemaker, defibrillator or other electronic implant
• •Subject requires supplemental oxygen.