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The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

The Cardima Ablation System consists of the disposable Cardima Ablation Probe with Stabilization Sheath, the reusable INTELLITEMP® energy management device, and associated cables.

The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy

Cardima® Ablation System

The NAVIPORT deflectable guiding catheter is intended to serve as a conduit for access into the chambers and coronary vasculature of the heart.

The NAVIPORT is a sterile, single use only, dual lumen, deflectable tip, guiding catheter with various curve reach configurations. NAVIPORT device is torquable and has a steering mechanism (control knob) in the handle. The control knob allows the catheter tip to be curved or to be straightened while the NAVIPORT is being routed to the desired location. The control knob is connected to an anchor ring located at the distal tip of the guiding catheter by a stainless steel pull wire. The pull wire runs from the control knob through a small closed lumen which terminates at the anchor ring. The anchor ring function is to allow the tip of the catheter to be deflected from the handle. A large central continuous lumen with a female luer at the proximal end and the deflectable tip at the distal end serves as a conduit for medical devices to the cardiovascular system.

The Tracer diagnostic mapping device is intended for use in cardiac multations For Ose. This catheter can be used to temporarily record epicardial electrical signals from the coronary sinus. The Tracer catheter can be used to temporarily pace during the mapping procedure.

The Cardima Tracer Over-the-Wire Mapping Microcatheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials as measured from within the venous system of the heart. The Tracer catheter can also be utilized for temporary epicardial pacing during the mapping procedure. The catheter is designed to accommodate a 0.010" guide wire and is available in five configurations with either 4, 8, or 16 electrodes. Both the 4 and 8 electrode catheters come with either regular spaced electrodes of 5mm or electrode pair spacing of 2-5-2 mm. The 16 electrode catheter is available only with 2-5-2mm pair spacing. The outer diameter of the catheter is 3.2F - 3.3F and will be available with working lengths of 145cm. The outer surface is treated with a hydrophilic coating to enhance lubriciousness. The Tracer is not indicated for ablation.

The Cardima EP SELECT Switchbox is an accessory intended to provide selective connection of multi-electrode catheters for electrogram recording and pacing during diagnostic electrophysiology studies.

The Cardima EP SELECT Switchbox is a passive switching unit used in conventional electrophysiology (EP) diagnostic procedures. It is designed to provide a convenient means by which the user can record or pace from multiple unipolar or bipolar intracardiac electrodes. The device is designed to be placed on a horizontal surface or at the patient's side. It is designed to accept up to eight electrodes using standard pin connectors typically found in the EP lab. Switching between record or pace modes is accomplished by a simple switch for each electrode.

The Cardima Pathfinder 1.5F Microcatheter is intended for electrogram recording from within the coronary venous system during diagnostic electrophysiology studies.

The Cardima Pathfinder® 1.5F Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials as measured from within the venous system of the heart. The catheter is available with 4, 1mm long electrodes spaced either 2mm or 2-6-2mm apart providing for a total electrode recording length of 10-14 mm. The working outer diameter is 1.5F and will be available with working lengths of 135cm and 170cm. The Pathfinder is not indicated for pacing or ablation. The outer surface is treated with a hydrophilic coating to enhance lubriciousness.

The Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter is intended for temporary occlusion of the coronary sinus ostium during a venogram and to serve as a conduit for access to the coronary venous system. The VUEPORT is intended for use to access the coronary sinus and perform occlusive venograms. The catheter may serve as a conduit for the delivery and support of other devices.

The Cardima Vueport™ is a sterile, single use only, dual lumen, balloon tipped guiding catheter with various tip configurations. The Cardima Vueport™ is a "Y" connector and each branch of the "Y" houses a lumen. The smaller lumen extends from a one-way stopcock (vented and included with the Vueport), to inflate the balloon and is used for air delivery and withdrawal. The connector on a female luer is attached to the occluded lumen to perform a coronary venogram. The larger lumen is a guide to the coronary sinus vasculature for the delivery of other devices and has an open atraumatic catheter tip.

The Cardima Pathfinder® 3mm Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials in the heart. The Pathfinder is also indicated for pacing. It is contraindicated for ablation. The Cardima Pathfinder 3mm catheter is intended for electrogram recording and pacing during diagnostic electrophysiology studies.

The Cardima Pathfinder® 3mm Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials in the heart. The catheter is available with 4 or 8, 3mm long electrodes spaced 2mm apart providing for a total electrode recording length of 4cm. The working outer diameter of the catheter is 3.3F and will be available with useable lengths of 100cm and 135cm. The Pathfinder is also indicated for pacing. It is contraindicated for ablation. The outer surface is treated with a hydrophilic coating to enhance lubriciousness.

Both devices are made to aid physicians specializing in cardiac electrophysiology, cardiac surgery and interventional cardiology in the management of abnormal rhythms of the heart. The main function of both devices is diagnostic sensing of electrical impulses in the heart muscles to provide precise, localized data.

The 2.5 Fr. Pathfinder Electrode Recording Catheter is a diagnostic medical device designed to sense electrical signals by use of multiple electrodes placed on the distal end of the catheter, each of which is connected to a connector at the proximal end of the catheter by means of a conductor wire. The connector is matched with a connector cable which functions to link the catheter to a standard ECG recording/monitoring system. The device is a composite construction of biocompatible materials commonly used in other (FDA) approved catheters. The catheter is available in 4. 8 and 16 electrode configurations and provides for a distal electrode recording length of up to 7 cm. The working outer diameter of the catheter is 2.3F or 2.5F depending upon the number of electrodes. The useable lengths are 100, 135. 150 and 200cm.