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Neonav is indicated for navigation and positioning of central venous access devices (CVADs) of at least 1Fr in size. Neonav provides real-time catheter tip location information by using the patient's cardiac electrical activity. Neonav is indicated for use as an alternative method to chest X-ray and fluoroscopy for all central venous access device tip placement confirmation. In adult patients and in adolescents (greater than 12 through 21 years of age), Neonav can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Neonav can be used with CICCs; in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Neonav can be used with PICCs and CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use. Limiting but not contraindicated situations for use of the Neonav are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous access device insertion, the use of an additional method is required to confirm catheter tip location.

The Neonav ECG Tip Location System (Neonav) is a non-invasive medical device that analyzes electrocardiographic signals (ECG) to track the location of central venous access devices (CVADs) in patients' blood vessels during placement in real time via a display. Catheter position in the vasculature is analyzed based on the patient's intravascular ECG (I-ECG). An I-ECG is recorded via the catheter tip from within the blood vessels of a patient. For the conductive fluid method, the sterile Neonav ECG Adapter Cable are used whereas for guidewire/stylet method, the sterile Neonav ECG clip cable is used. These components allow the electrical impulses detected at the catheter tip to be recorded by a non-sterile Acquisition Unit and analyzed by the Neonav Console to assist in determining the catheter tip position. The Neonav Controlled via a touch screen interface or a Remote enclosed in a sterile cover. The Neonav Console displays real-time surface ECG and I-ECG signals, highlighted QRS complex, max measured P-wave, the patient's heart rate, and other device performance indicators. A surface electrode is placed on the subject to act as a reference electrode. A second surface electrode is placed on the subject for noise reduction. Neonav components are designed to attach easily to standard catheter and IV therapy components via standard luer lock connections. The only patient contacting component of the ECG Adapter. It has indirect contact with the patient via fluids and is composed of biocompatible polycarbonate and stainless steel.