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The VIKING Fixed Curve Diagnostic Catheter is indicated for use to diagnose cardiac arrhythmias.

The Viking Fixed Curve Diagnostic Catheters (also referred to as Viking Catheters) are intended for use in electrophysiology procedures to record, stimulate and pace in the diagnosis of cardiac arrhythmias. The Viking Catheters receive electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter into the vasculature percutaneously. To reach the right side of the heart, either the internal jugular vein, the subclavian veins, or the femoral veins can be accessed. To reach the left ventricle, the retrograde approach via the femoral artery can be used. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism, as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface. Viking Catheters are radiopaque, flexible, insulated catheters. The catheters have a polymer shaft that houses the electrical wiring that connects the electrodes to a connector at the proximal end of the catheter; each electrode wire is soldered into this connector. When the catheter is used, the connector is attached to a sterile cable that connects to the hospital recording and pacing equipment. The Viking Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

The unidirectional steerable diagnostic catheters acquire electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter(s) percutaneously via either the anterior approach using the internal jugular vein or the subclavian vein or via the femoral vein or for a retrograde approach, via the femoral artery. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface. The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The EP+XT Catheter has a white rotating handle mechanism which provides curve actuation of the distal tip. The Dynamic Tip and Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip. The EP•XT, Dynamic Tip, and Dynamic XT Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

The Nordica PV Cryo Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.

The Nordica PV Cryo Mapping Catheter is a 3F sterile, single use, multi-electrode, diagnostic catheter designed to map cardiac signals during ablation procedures. The catheter is provided with a fixed loop diameter of 15mm or 20mm with either 5 or 4 evenly spaced, radiopaque pairs of electrodes. The proximal end of the catheter contains an electrical connection for the EP electrical cable that integrates with electrophysiology lab recording systems. Once deployed in the vasculature through the central lumen of a catheter, a circular or spiral shape is established such that the electrodes contact the endocardial surface. This allows for recording, pacing, and interrogation of electrical conduction between the left atrium and the pulmonary veins.

The Cosine-10 Diagnostic Catheter is indicated for electrophysiological mapping (stimulation and recording) of cardiac structures, including in the coronary sinus.

The Cosine-10 Diagnostic Catheter is a sterile, single-use, steerable decapolar mapping catheter with a bidirectional deflecting tip intended for electrophysiological mapping of cardiac structures (i.e., stimulation and recording). The catheter contains 10 electrodes spaced in 5 pairs, including a distal dome electrode. Two electrode spacing configurations are available: 2-8-2 (AFR-00017) or 2-5-2 (AFR-00018). All catheter electrodes may be used for recording or stimulation. The catheter can be used with a compatible introducer sheath (7.5Fr minimum).

The Polaris X catheter is indicated for use to diagnose cardiac arrhythmia.

The Polaris X Unidirectional Steerable Diagnostic Catheter is a sterile, single use, unidirectional, steerable, diagnostic catheter intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. The catheter consists of a distal electrode segment, a shaft and a handle. The distal electrode segment consists of 10 electrodes (decapolar); 1 tip electrode that is 2 mm in length and 9 ring electrodes in a variety of electrode spacings, as detailed in Table 1. The distal electrode segment is capable of forming a 270° standard curve configuration. The shaft of the Polaris X catheter has a 6 French (F) outer diameter and a useable length of 105 cm. The proximal end of the shaft is connected to a handle, which contains a patented thumbslide steering control that actuates the curve. This catheter is compatible with most commercially available recording and mapping systems and connects to these systems via a cable, which is available separately.

The Blazer Dx-20 Catheter is indicated for use to diagnose cardiac arrhythmia.

The Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter is a sterile, single use, steerable, diagnostic catheter intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. The catheter is provided in two different bidirectional curve configurations, Medium (25 mm diameter) and Super Large (56 mm diameter), to assist the physician in reaching the desired anatomical location. The distal electrode segment of the catheter contains an electrode tip and 19 electrode rings which are designed to carry electrical signals for endocardial stimulation (pacing) and/or recording. The electrode rings are placed on the distal segment of the catheter in various electrode spacing configurations, as described in Table 1. A 7F torqueable shaft connects the distal electrode segment to an ergonomically designed cylindrical handle. The catheter handle contains both a steering knob and tension control knob. The degree of tip deflection of the catheter is controlled by the steering knob. The adjustable tension control knob can be tightened to hold the tip in the desired position This catheter is compatible with most commercially available recording and mapping systems and connects to these systems via a cable, which is available separately.

Blazer Dx-20 Catheter Cable: The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials. Polaris X Catheter Cable: The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Blazer™ Dx-20 Cable: The subject Blazer Dx-20 Catheter cable (sold separately) is used with the Blazer Dx-20 Bidirectional Duodecapolar Catheter during an electrophysiology procedure. The Blazer Dx-20 Catheter Cable provides an electrical connection between the Blazer Dx-20 Diagnostic Catheter and the Electrophysiology (EP) Recording System. The cable has one connector that directly connects to the diagnostic catheter and multiple connection points that connect to an EP Recording System. The main trunk consists of a jacketed 20-conductor cable that is split into individual leads by means of an over-molded splitter yoke. The proximal end of the cable has 20 universal 2 mm shrouded male pins that are typical to electrophysiology recording and stimulation systems. The Blazer Dx-20 cable is provided sterile using an EO sterilization process. The cable is reusable and can be reprocessed (i.e. re-sterilized) up to 10 times using either EO or STERRAD™ sterilization methods. The Blazer Dx-20 cable is to be used in a fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures. Polaris X™ Cable: The subject Polaris X Catheter Cable (sold separately) is used with the Polaris X Steerable Decapolar Mapping Catheters during an electrophysiology procedure. The Polaris X cable provides an electrical connection between the Polaris X Catheter and the Electrophysiology (EP) Recording System. The cable has one connector that directly connects to the diagnostic catheter and multiple connection points that connect to an EP Recording System. The main trunk consists of a jacketed 10-conductor cable that is split into individual leads by means of an over-molded splitter yoke. The proximal end of the cable has 10 universal 2 mm shrouded male pins that are typical to electrophysiology recording and stimulation systems. The Polaris X cable is provided sterile using an EO sterilization process. The cable is reusable and can be reprocessed (i.e. re-sterilized) up to 10 times using EO sterilization method. The Polaris X cable is to be used in a fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures.

EasyFinder™ Fixed Curve Diagnostic Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.

The EasyFinder™ Fixed Curve Diagnostic Catheter is a sterile, single-use diagnostic catheter with multiple electrodes and a fixed distal curve. It has been designed to facilitate electrophysiological mapping of cardiac structures in 28 models and 6 kinds of curves. The catheter has a high-torque shaft with a fixed curve section containing an array of platinum electrodes. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the FORLNK™ Cable for Mapping Catheter.

The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The IntellaMap Orion™ High Resolution Mapping Catheter (Orion catheter) is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bidirectional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve on an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the RHYTHMIA HDx™ Mapping System.