Atrial fibrillation (AF) affects more than 33 million people worldwide1. Cryoballoon ablation is used in a minimally invasive procedure to isolate the pulmonary veins, which are a source of erratic electrical signals that cause AF. The technology uses cold energy rather than heat (radio frequency (RF) ablation) to create scar tissue and interrupt these irregular electrical pathways in the heart.
“This integrated solution can guide physicians during the treatment of AF patients with ablation, as they can view detailed, CT-like 3D anatomy, reducing the need for X-ray imaging,” said Marlou Janssen, Business Leader Philips EPD Solutions. “Partnering with Medtronic extends the reach of our KODEX-EPD cardiac imaging and navigation system. Today, this technology is simplifying navigation, and in the future it has potential for a wide range of applications, including addressing the key unmet need of real-time therapy assessment—one of the more significant limitations of the current standard of care.”
"When available, physicians will have the ability to use an innovative cardiac imaging and mapping system during cryoablation procedures, while also realizing the significant benefits of our best-in-class cryoablation therapy," said Rebecca Seidel, vice president and general manager of the Atrial Fibrillation Solutions division, which is part of the Cardiac and Vascular Group at Medtronic. “AF is a growing epidemic and we are committed to providing solutions to electrophysiologists that help address the needs of their patients."
Philips’ KODEX-EPD system uses dielectric imaging to create CT-like 3D, high-definition images of a patient’s cardiac structures in real time2. A completely new approach to imaging the heart, dielectric imaging offers many benefits in comparison to current approaches, for both cryo and RF ablation procedures. The technology provides real-time 3D imaging, reducing the need for X-ray imaging. It also has mapping capabilities without the need to reset a reference point if the patient moves. As a result, the KODEX-EPD system provides excellent visualization and simplifies navigation, enhancing procedure efficiency and patient care.
In pulmonary vein isolation (PVI) cryoablation procedures, the system confirms the positioning of the Medtronic Achieve Mapping Catheter, supporting quick visualization of the pulmonary veins. Philips is also developing balloon visualization capabilities for the KODEX-EPD system.
KODEX-EPD is CE marked and has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for mapping and navigation during arrhythmia ablation procedures. KODEX-EPD systems are in clinical use at limited sites worldwide. The integrated solution to support cryoablation procedures is intended to be available for sale in the U.S. and Europe in Q4 2019.
1 Chugh S, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation. 2014; 129:837-847.
2 Maurer T, Kuck K-H et al. First clinical experience in high-resolution imaging of left atrial anatomy using a novel wide-band dielectric mapping system. Clin Res Cardiol 108, Suppl 1, April 2019.