PercAssist PSCA Hemodynamic Support System Evaluated in EUREKA FIH Study

September 28, 2023—PercAssist, Inc., which is developing a minimally invasive, extravascular platform to provide hemodynamic support for chronic heart failure patients, announced the successful treatment of the first patient in the EUREKA first-in-human (FIH) clinical study.

The PercAssist percutaneous synchronized cardiac assist (PSCA) system is designed for extravascular placement to provide hemodynamic support for chronic heart failure patients without the need for anticoagulants. The PSCA system consists of a balloon-based catheter and console. It inflates and deflates in synchrony with the patient’s cardiac rhythm to provide hemodynamic support.

In the FIH procedure, the PSCA system was successfully deployed and provided hemodynamic stability immediately after implantation and throughout the implant period. The procedure was performed at the Na Homolce Hospital in Prague, Czech Republic, under the direction of Principal Investigator Professor Petr Neuzil, MD, with Coinvestigators Professor Ivo Skalsky, MD, and Marek Janotka, MD.

“We are extremely excited to lead the FIH clinical investigation of the PercAssist PSCA system for chronic heart failure patients requiring hemodynamic support,” commented Prof. Neuzil in the company’s press release. “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.”

Prof. Neuzil continued, “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.”

According to the company, the PercAssist system 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.

Although the clinical assessments are at an early stage, PercAssist plans to complete the FIH study, which will be followed by a multicenter feasibility and pivotal trial that will be conducted under an FDA investigational device exemption for market approval.

The PSCA system is not available for sale in the United States or internationally and is for clinical investigational use only, advised PercAssist in the company’s press release.

Additionally, the company advised it is initiating Series B financing to support continued clinical investigations of this technology.