PercAssist, Inc., a medical device company developing innovative technology for a minimally invasive, extravascular platform to provide hemodynamic support for chronic heart failure patients, today announced the successful completion of its first patient in the EUREKA First-in-Human clinical study.
The case was completed at the Na Homolce Hospital, Prague, Czech Republic, under the direction of principal investigator Professor Petr Neuzil, M.D., Ph.D., FESC, along with co-investigators Professor Ivo Skalsky, M.D., Ph.D., and Marek Janotka, M.D. Professor Neuzil and his clinical team successfully deployed the PercAssist Percutaneous Synchronized Cardiac Assist (PSCA) System, consisting of a balloon-based catheter and console, which inflates and deflates in synchrony with the patient’s cardiac rhythm to provide hemodynamic support. The PSCA System was successfully deployed and provided hemodynamic stability immediately following implantation and throughout the implant period.
“We are extremely excited to lead the First-in-Human clinical investigation of the PercAssist PSCA System for chronic heart failure patients requiring hemodynamic support,” said Professor Neuzil. “Our first patient experienced an increase in ejection fraction of approximately 10% and an increase in cardiac output, sustained throughout the implant period without any adverse events. This extravascular ventricular assist technology has tremendous potential for providing hemodynamic support for heart failure patients without the need for anticoagulation therapy. Our team is excited to evaluate this innovative technology; it is a revolutionary advance for our field.”
The PercAssist System is a medical device that enables first-line interventional cardiologists and cardiac surgeons to provide an extravascular solution for chronic heart failure patients in need of hemodynamic support for an acute event, including cardiogenic shock or acute decompensated heart failure. While the clinical assessments are at an early stage, PercAssist plans to complete the First-in-Human study, followed by a multi-center Feasibility and Pivotal Trial under the U.S. Investigational Device Exemption (IDE) for market approval.
“This successful First-in-Human case comes after three years of rigorous design and development activities, including design verification and validation testing, and numerous pre-clinical acute and chronic assessments,” said Gerardo Noriega, president and CEO of PercAssist. “This milestone marks the beginning of our efforts to bring this potentially groundbreaking, novel technology to heart failure patients on a global scale.”
Source: Company Press Release
