EpiEP, Inc. Receives FDA 510(k) Clearance for EpiAccess System™
Pressure-guided epicardial access system enables electrophysiologists to perform challenging procedures on the surface of the heart
New Haven, Conn. - Nov. 10, 2014 – EpiEP, Inc. (EpiEP), today announced that its EpiAccess™ system, a pressure-guided epicardial access system designed to help physicians perform procedures on the surface of the heart, has received 510(k) clearance from U.S. Food and Drug Administration (FDA), a step that will allow EpiEP to commercially distribute the device.
EpiEP is a research and development medical device company with a portfolio of innovative epicardial technologies initially targeting minimally-invasive epicardial access for electrophysiology procedures such as ventricular tachycardia (VT), atrial fibrillation (AF), and left atrial appendage occlusion (LAA), which in some instances require access to the surface of the heart.
“This clearance marks a significant advance for EpiEP and our lead product,” said Pamela Bunes, CEO of EpiEP. “The EpiAccess™ system is positioned to immediately impact the growing field of epicardial electrophysiology procedures. We look forward to launching the EpiAccess™ system to full commercialization in the U.S. and providing physicians with a unique device that allows them to access the pericardial space, which surrounds the heart.”
The EpiAccess™ system is the flagship product, which provides electrophysiologists a pressure guided access needle. Pressure guidance allows the physician to know where the needle tip is located when it is advanced under fluoroscopic guidance to the virtual space between the pericardial sac and the surface of the heart without injuring the heart. It was CE Mark (Conformité Européenne) approved for sale in Europe in March 2014, and has been used in a post-market study in Prague, Czech Republic, Milan, Italy, Bordeaux, France, and Coimbra, Portugal.
“Despite the growing importance of epicardial access during ablation procedures, it is recognized that the fear of potential complications has limited the use of an epicardial approach,” said Andrea Natale, M.D., and Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas. “The EpiAccess™ system is the first product designed and approved for use in Europe and FDA 510(k) cleared in the United States that will offer physicians more confidence to use this approach whenever it could be beneficial to the patient.”
Editor’s Note: The EpiAccess™ system is not available for sale or use in all countries. For additional information, please visit www.epiep.com.
Source: EpiEP, Inc.
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