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The Guidant SYNCRUS™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

The Syncrus System consists of three components: - Three temporary heart wires sutured onto the heart during open-heart surgery. The wires include a unipolar defibrillation heart wire (left atrium), a bipolar pacing/sensing heart wire (right or left ventricle) and a tripolar defibrillation and pacing and sensing heart wire (right atrium). - An attenuator box (External Defibrillator Interface Module EDIM). The EDIM attenuates the delivered energy from a standard, low energy defibrillator by 97% (50 - 360 Joules to 1.3 - 11.5 Joules). - A cardioversion extension cable, which connects the defibrillation heart wires to the EDIM. The user must supply an external, low-energy defibrillator that is capable of synchronized cardioversion, an external pacemaker, and temporary patient cables to connect the pacemaker to the patient. The Syncrus System is designed to perform the following cardiac rhythm management functions: - Atrial pacing and electrocardiogram sensing - Ventricular pacing and electrocardiogram sensing - Atrial defibrillation using low energy, synchronized cardioversion.

The Guidant Syncrus™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

The Syncrus Heart Wires and Connectors are used for atrial and ventricular pacing and electrocardiogram sensing to diagnosis and treat atrial (type I) flutter and some forms of tachycardia. The wires are also used to treat post-operative arrhythmias, particularly atrial fibrillation, when used in conjunction with the Syncrus Cardioversion Extension Cable and Syncrus External Defibrillator Interface Module (EDIM). The EDIM is a passive device. The EDIM when used with a compatible external monophasic defibrillator reduces the energy to approximately 3% and delivers the low-energy cardioversion shock directly to the atria. The cardioversion is achieved by delivering a synchronized electrical pulse of approximately 11.1 Joules or less to the atrial chambers of the heart. There are three types of Heart Wires: - A tripolar atrial wire, capable of pacing and sensing, and cardioversion, when used in conjunction with the unipolar wire. - A unipolar atrial wire, capable of cardioversion when used in conjunction with the cardioversion electrode on the tripolar wire. - A bipolar ventricular wire, capable of pacing and sensing. The wires are comprised of curved needle(s), attached to lead(s) on the proximal end. The wires are insulated for long length. A straight needle is attached to the leads on the distal end of the wires. Cardioversion connectors are provided that attach to the appropriate heart wire leads. Pacing connector pins are pre-assembled onto the appropriate heart wire leads. The Syncrus Heart Wires are intended to be affixed to the surfaces of their respective heart chambers, during or immediately following open-heart surgery, before the median sternotomy is closed. Temporary pacing heart wires are routinely implanted in a similar manner. The unipolar atrial wire is placed on the left atrium, the tripolar atrial wire is placed on the right atrium, and the bipolar ventricular wire is placed on either ventricle. If all of the Heart Wires are implanted, the atrial and ventricular temporary sensing and pacing ability can be used, and only if the patient develops post-operative AF would the cardioversion feature be used. Both the unipolar atrial wire and the tripolar atrial wires are required in order to perform a cardioversion. When only the capability to treat post-operative AF is desired, the ventricular wire is not required. When the pacing feature is used, the pacing lead is inserted into the myocardial tissue of the atrium using the curved needles. Location and pattern of the lead is not critical, as the lead simply requires tissue contact. The "bullet" (define) on the ground wire is then pulled through the hole formed by the curved needle, and is thus buried in the myocardial wall.