First Patient Treated in Study of PercAssist’s PSCA System

PercAssist Inc. has successfully completed its first patient case 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. Neuzil and his clinical team successfully deployed the PercAssist Percutaneous Synchronized Cardiac Assist (PSCA) System, which consists of a balloon-based catheter and console that 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,” Neuzil said. “Our first patient experienced an increase in ejection fraction of approximately 10% (a 29% improvement over baseline) 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 device that enables first-line interventional cardiologists and cardiac surgeons to provide an extravascular solution for chronic heart failure patients who need 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. Food and Drug Administration Investigational Device Exemption (IDE) for market approval.
 
“This successful first-in-human case comes after three years of design and development activities, including design verification and validation testing, and numerous pre-clinical acute and chronic assessments,” PercAssist President/CEO Gerardo Noriega stated. “This milestone marks the beginning of our efforts to bring this technology to heart failure patients on a global scale.”
 
PercAssist is a privately held medical device company in Santa Clara, Calif., founded in 2019 to develop the Percutaneous Synchronized Cardiac Assist (PSCA) System—a product designed for extravascular placement to provide hemodynamic support for chronic heart failure patients without the need for anticoagulants. Proprietary PercAssist electrocardiogram (ECG) and implant technologies apply ventricular compression synchronized with the patient’s natural heart rhythm to help improve patients’ cardiac output. The company is initiating Series B financing to support continued clinical investigations of this technology. The PSCA System is not for sale in the United States or internationally and is for clinical investigational use only.