EPD has completed its first human procedure, having successfully tested its revolutionary D700 Dielectric Sensing System at the Meshalkin State Research Institute of Circulation Pathology in Novosibirsk, Russia, headed by Professor Evgeny Pokushalov. The EPD D700 System employs dielectric sensing for guided personalized intra-cardiac navigation, and provides electrode-tissue contact quality, real-time lesion assessment and gap detection for improved procedure efficacy and efficiency.
EPD D700 screenshot. The EP catheter is displayed and navigated within a pre-acquired 3D segmented CT image. The D700 provides a real-time lesion assessment tool that predicts transmurality and permanency of lesions, pre- and immediately post-ablation.
“We are pleased to have our doctors use the EPD D700 System for the first time in patients. I was impressed by the system ingenuity, the navigation of intra-cardiac catheters and the ability to deliver controlled, patient and site specific therapy to arrhythmia patients,” said Professor Pokushalov. “EPD’s novel swift registration and endoscopic navigation features simplify and shorten the procedure significantly, and the system’s lesion assessment is a breakthrough technology that allows us, for the first time, to predict the outcome of an ablation prior to delivering the RF energy to the heart and to verify its effect once it was delivered to the patient. We are excited to participate in the upcoming clinical studies to demonstrate the clinical benefits brought by the EPD revolutionary technology.”
Three consecutive symptomatic and drug-refractory atrial fibrillation patients were treated using customary fluoroscopy and CARTO guidance. The electrophysiologist performing the procedures assessed, for the very first time in human patients, the feasibility, usability and clinical applicability of the EPD D700 system for intra-cardiac navigation and guidance of therapeutic myocardial ablations. The impression made by the system’s functionality, swift registration and user-friendly navigation inside pre-acquired 3D CT images was very positive, and its ingenuity and intuitive endoscopic views were also highly praised. Overall, the EPD D700’s accuracy was comparable to current commercially available standards.
The EPD D700 Navigation System uses a variety of input data, including dielectric, mechanical, anatomical and thermal properties, and supports any standard EP catheter. The system provides real-time readings before, during and after ablation, validating the ablation permanency, transmurality and contiguity at both point and line levels.
“We are very excited about our early human experience results,” said Dr. Yitzhack Schwartz, Chief Medical Director at EP Dynamics Research. “Reaching this milestone in such a short time is a testimony to our determination, innovation and robust core technology. Our ability to provide a pre-ablation prediction of the likelihood of generating a permanent transmural lesion at a point level, together with our ability to monitor the ablation process in real-time and validate the end result immediately post-ablation, enforces our belief that the EPD system will drive a paradigm shift in field of clinical electrophysiology.”
About atrial fibrillation
Atrial fibrillation (AF) is an abnormal heart rhythm which is characterized by irregular and rapid beating. As the most common arrhythmia, it affects about 3% of the population in North America and Europe and is the second leading cause of stroke.
About EP Dynamics
EP Dynamics (EPD), a member of the Hobart Group companies, is dedicated to improving the efficacy and efficiency of minimally invasive catheter-based procedures performed to treat cardiac arrhythmias. EPD is developing a proprietary dielectric-based platform that enables the measurement of the permanency, transmurality and continuity of cardiac AF ablation lesions, thereby significantly improving the efficacy of AF ablation. The platform also provides an estimated ablation depth, reports catheter contact quality and gives an accurate 3D localization of EP catheters. For more information, please visit www.epd-medical.com.
About Hobart Group
The Hobart Group develops and commercializes medical technologies which target top healthcare markets with significant unmet needs. Its growing portfolio of companies covers the areas of cardiology, diabetes, oncology, neurology and rehabilitation. Together, Hobart Group companies have over 200 scientists, engineers, regulatory and business experts across four continents, benefitting from clinical expertise and extensive regulatory and international market knowledge across Europe, the USA and Asia. For more information, visit www.Hobart-Group.com.