How do you navigate a maze system through the FDA regulatory maze? St. Jude Medical has done it for company’s “second generation” Epicor™ High Intensity Focused Ultrasound (HIFU) system. The device, designed for the intraoperative maze treatment of atrial fibrillation, has been approved by the American regulators, and it has also received European CE Mark of approval. Epicor is designed to perform epicardial left atrial lesions in a variety of open heart cases, both on- and off-pump, such as OPCABs, valve repair, valve replacement, or good old CABGs.
System components from the product page:
The 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 storage and recall of procedural and system information. Three generators provide consistent three-phased ablative energy through all layers of tissue, without concerns for tissue depth or the need for fat dissection.
The UltraCinch™ Ablation Device – The UltraCinch device enables creation of a uniform, continuous, linear lesion 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 seven sizes to accommodate varying patient anatomies.
The UltraWand™ Handheld Ablation Device – Using the same transducer technology as in the UltraCinch device, the UltraWand allows complimentary linear lesions to be created during cardiac ablation procedures. This provides physicians with the flexibility to create the lesion set that is most appropriate for each patient.
The Epicor™ Positioning and 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.