Search Results

The N-SWEAT Patch is indicated for treatment of primary axillary hyperhidrosis in adults.

The N-SWEAT Patch is composed of metallic sodium on a polyester tape. This sodium bilayer is mounted to a polyethylene medical tape (adhesive backing) and covered with a release liner which is removed prior to application. The non-sterile packaged in an impermeable, argon filled, foil pouch. The packaging protects the patch during transit and storage, preventing exposure to the environment including water and air. The device is provided non-sterile and is not intended to be sterilized. A disposal kit is provided with each N-SWEAT Patch to deactivate the patch after use. The kit includes a prefilled bottle of deactivation solution, a cover paper, and a plastic bag. The N-SWEAT patch is a non-invasive, single-use topical patch device. The N-SWEAT patch is a thermal energy-based medical device that is activated by water released from sweat glands. When applied to a dry axilla by a clinician. the sodium bilayer in the patch interacts with the water component of sweat causing the patch to generate thermal energy as well as the byproduct sodium hydroxide (NaOH) (sodium hydroxide does not contribute to the therapeutic mechanism). The rapid exothermic reaction between sweat (water) and sodium is limited by both the amount and location of the sweat. The thermal energy temporarily inactivates sweat glands leading to a reduction in sweat production. In the absence of sweat, no thermal energy is generated. The release liner is removed immediately prior to the treatment. The reactive material is a thin layer of sodium, which interacts with the patient's sweat to deliver the treatment. The polyethylene adhesive backing on which the sodium bilayer is mounted holds the patch in place during the treatment. The argon gas provides an inert environment in the packaging to prevent the patch from oxidizing and to increase the shelf life. The N-SWEAT Patch is applied by a clinician to the surface of dry, unabraded, intact skin of the axilla. After the skin is cleansed and dried, the release liner is removed, and the device is applied to the skin for up to 3 minutes in a physician's office or clinic. The entire device is then removed and disposed of by medical personnel. The skin is then cleansed with water to remove any sodium hydroxide residue.