Epicor™ Cardiac Ablation System
This device is commercially available for use in the United States and select international markets.
Controlled Energy Delivery for Safe, Effective and Reproducible Outcomes
The Epicor Cardiac Ablation System uses the control and precision of High Intensity Focused Ultrasound (HIFU) energy to replicate proven ablation lesion sets epicardially, without the need to place the patient on a heart-lung bypass machine. Because HIFU energy can be applied to the outside of a beating heart (epicardially) and can precisely ablate the entire thickness of the atrial wall without harming nearby tissue, it provides outstanding safety, efficacy and reproducibility not possible with other energy sources.
Due to the Epicor Cardiac Ablation System’s epicardial and off-pump application, it can be used prior to valve repair, valve replacement, or coronary artery bypass graft (CABG) procedures, adding less than five minutes to the overall procedure time.
The Epicor Cardiac Ablation System consists of the following components:
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UltraCinch™ Ablation Device – The UltraCinch device enables creation of a uniform, continuous lesion (also known as the box lesion) in a single step around all four pulmonary veins during cardiac ablation. It can be placed securely around the patient's atrium while transducers apply HIFU energy safely and precisely through the targeted tissue. The UltraCinch device is offered in six sizes to accommodate varying patient anatomies.
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UltraWand™ Handheld Ablation Device – Using the same transducer technology as in the UltraCinch device, the UltraWand allows complementary linear lesions to be created during cardiac ablation procedures. This provides physicians with the flexibility to create additional discrete lesions such as the mitral line (a lesion extending from the left inferior pulmonary vein to the mitral annulus).
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Epicor Positioning & Sizing (PAS) System – The Epicor PAS System is dual-purpose, designed to indicate the proper UltraCinch device size and act as a guide for simple, accurate placement of that device. It is designed to track smoothly through the cardiac anatomy, and to facilitate less invasive approaches. The tourniquets ensure secure placement of devices on the patient's heart.
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Epicor Ablation Control System (ACS) - The ACS is designed for consistent, effective delivery of HIFU energy. It features an intuitive user interface, single-button control of ablation cycles, and convenient real-time monitoring and display of parameters such as power delivery and temperature. Three generators provide consistent three-phased ablative energy through all layers of tissue, without concerns for tissue depth or the need for fat dissection.
