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The Ablamap® System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The Ablacon Ablamap System is an electrophysiology mapping system used during electrophysiology procedures for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and a workstation with proprietary patented mapping software. Electrogram (EGM) signals are detected by 64-electrode mapping "basket" catheters which are input into, sampled, and amplified by the system's amplifier. The data is transmitted via fiber-optic cable from the amplifier to the workstation and processed by the system's mapping software with the results displayed on the monitor. The system also accepts EGM data files recorded by EP amplifier recording systems from 64-electrode unipolar "basket" mapping catheters. The EGM data files are electrophysiology (EP) recordings that contain electrogram signals recorded by EP recording systems using 64-electrode "basket" mapping catheters. Compatible EP recording systems are the Boston Scientific LabSystem Pro™, the GE Healthcare CardioLab™ XT, and the St. Jude Medical WorkMate™ Claris System. The recorded EGM data files are saved onto the workstation and processed by the mapping software. Compatible catheters are 64-electrode mapping "basket" catheters with the following dimensions: 50mm and 60mm sizes; an 8 spline x 8 electrode configuration with nominal electrode spacing of 0.354'' and 0.440" for 50mm and 60mm basket sizes respectively. Through the software user interface, the user selects to record streamed EGM data from the Ablamap System signal amplifier that is saved to the workstation or the user selects an EGM data file recorded by an EP Recording System that has been saved to the workstation. The data file is processed by the Ablamap System software where the EGM signals are converted into electrographic flow® (EGF®) maps indicating flow consistency and direction of the action potential wave propagation during pre-defined time intervals. The resulting EGF® film maps display the flow with respect to the catheter electrodes and show the activity of sources of excitation where action potentials originate. A Summary Map is displayed that is the graphical representation of the summation of the activity of EGF® sources from all segments of the EGM data file recording indicating the rate of occurrence i.e. prevalence of sources of EGF® with respect to the catheter electrodes. These graphical maps are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias during electrophysiology procedures.

For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Ablacath™ Mapping Catheter may also be used for delivery of externally generated pacing stimuli.

The Ablacath™ Mapping Catheter is a sterile, single use device used to detect electrical potentials from the endocardial surfaces of the heart. They may also be used to deliver externally generated pacing stimuli. These signals may be used for analysis with a 3-D mapping system. The catheter's distal end is an expandable basket with eight (8) longitudinal splines each having eight (8) electrodes spaced equal distance along the length of the spline. When expanded it forms a spherical or basket shape. An integrated Introducer Tool collapses the basket for insertion into an 8.5 F sheath. The Ablacath Mapping Catheters are available in two (2) model numbers representing two (2) basket sizes.

The Ablamap® Software is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The Ablacon Ablamap® Software is a stand-alone software device that uses a proprietary patented algorithm to process electrogram (EGM) signals from data files. The EGM data files are electrophysiology (EP) recordings that contain intra-cardiac electrogram signals recorded by EP recording systems using Abbott Electrophysiology FIRMap™ Catheters, 50mm and 60mm sizes; cleared under 510(k) K163709; a 64-electrode "basket" mapping catheter. The EP recording systems used are the Boston Scientific LabSystem Pro™, the GE Healthcare CardioLab™ XT, and the St. Jude Medical WorkMate™ Claris System. The recorded EGM data files are saved onto a computer with the Ablamap® Software installed. The user selects an EGM data file through the software user interface and the file is processed by the software where the EGM signals are converted into electrographic flow (EGFTM) maps indicating relative velocity and direction of the action potential wave propagation during predefined time intervals. The resulting EGF™ film maps display the flow with respect to the catheter electrodes and show the activity of sources of excitation where action potentials originate. A prevalence map is displayed that is the graphical representation of the activity of EGF™ sources from all segments of the EGM data file recording indicating the rate of occurrence i.e. prevalence of sources of EGF™ with respect to the catheter electrodes. These graphical maps are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias during electrophysiology procedures. The Ablamap® Software may be installed on any commercially available workstation personal computer (PC) with a Linux Ubuntu 18 LTS operating system and that meets minimum requirements for CPU and GPU processing, random access memory (RAM), and hard drive size.