What we've been up to
EpiEP, Inc. is a medical device company that has developed an FDA cleared and CE marked epicardial access system, EpiAccess™. This system engages a patent protected pressure-guided needle that is designed to alert physicians of needle tip location during epicardial access procedures.
Entering the pericardial space with a minimally invasive technique is considered the “final frontier” for electrophysiology procedures. EpiEP has devoted itself to developing a specialized instrument that will facilitate an epicardial approach for patients who will benefit from minimally invasive procedures on the surface of the heart.
An epicardial approach allows the physician to work on the outside surface of the heart muscle rather than on the inside of the heart. While several companies have emerged with epicardial tools for treatment of ventricular tachycardia (VT), atrial fibrillation (AF), and left atrial appendage (LAA) ligation, EpiEP's solution uniquely employs a pressure guided needle in conjunction with standard of care fluoroscopy to provide the physician with safe, precise, real-time guidance confirming access into the pericardial cavity.
During pre-clinical and clinical trials, physicians have expressed satisfaction with the performance of the EpiAccess™ System and its unique ability to display adjunctive data, designed to permit the physician to recognize when the needle tip reaches the pericardial space. This is a technology platform that can be calibrated for other anatomic locations within the body, but to date our focus has been the development and commercialization of the EpiAccess™ System to provide pressure guided access to the pericardial space.
May 2015Completed EASe Post-Market Clinical Study
October 2014FDA 510(k) clearance for EpiAccess™ System
August 2014FDA submission completed
March 2014EpiAccess™ System CE Marked
2013 - 2014Multi-center clinical trial in Europe
(Prague, Czech Republic; Milan, Italy; Coimbra, Portugal; Bordeaux, France)
December 2013EpiEP receives ISO 13485 Certification
2012Feasibility study completed in Europe
(Prague, Czech Republic; Debrecen, Hungary)
May 2012Findings from pre-clinical trial presented at Heart Rhythm Society meeting
May 2011Pre-clinical trial at Mayo Clinic
2010First product design
December 2008Company formed