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Northstar System is indicated for the administration of lidocaine hydrochloride to provide local dermal anesthesia on normal intact skin. This system is an alternative to hypodermic injection or topical application of lidocaine hydrochloride. Northstar System is indicated for use on patients 5 years of age and older.

The Northstar Lidocaine Iontophoretic Drug Delivery System (Northstar System) is composed of the Controller and the pre-medicated Patch. The Controller is fitted with a unique interconnect device, mating only with the Northstar Patch. The Northstar System delivers drugs through a process known as iontophoresis. It is based on the principle that a soluble salt or drug can be transported across the skin barrier as a part of an electric current induced in the skin. The quantity and distribution of delivered drug(s) is dependent on; ion charge, molecular weight, the intensity of the electric current and the time the current is present. In most iontophoretic systems the delivery is measured in terms of milliampere-minutes (mA-min). It has been shown that the efficacious delivery of anesthetic levels of lidocaine hydrochloride can be made to local dermal areas through iontophoresis. The Northstar Controller-D uses a combination of discrete analog circuitry to control the delivery current and an embedded microprocessor to monitor the delivery. The Northstar System utilizes a solid-state electronic controller and a pre-medicated drug delivery patch to form a simplified iontophoretic drug delivery system. As a result of this product design coordination, the Northstar System requires no special patch preparation or delivery parameter selection in the controller. An ON button actuation turns on an LCD (Liquid Crystal Display) indicating the number of deliveries available, starts the delivery and two LED's (Light Emitting Diodes) on the controller indicate the delivery status to the user. The Northstar System has been specifically designed for the delivery of a proprietary preparation containing 10.0% Lidocaine hydrochloride and 1.0% Epinepherine packaged in a pre-filled patch. The delivery is done over a 10 minute interval. The user simply applies the patch to the patient, connects the controller and patch then depresses the ON button to start the delivery.