SANTA CLARA, Calif.--(BUSINESS WIRE)--PercAssist, Inc., a medical device company developing innovative technology for extravascular / extracardiac Mechanical Circulatory Support to provide hemodynamic improvements for patients in cardiogenic shock (CS), today announced that new data was presented at two sessions at the Transcatheter Cardiovascular Therapeutics (TCT24) Conference in Washington, DC, Oct. 27-30, 2024.
“It was an honor to present the PercAssist Percutaneous Synchronized Cardiac Assist (PSCA) Technology, which is a truly novel approach in the treatment of cardiogenic shock,” said Gerardo Noriega, president and CEO of PercAssist. “The extravascular, intrapericardial balloon implant requires no large vessel access, and the system avoids many of the current standard of care complications, such as major bleeding, hemolysis, limb ischemia, stroke, infection and sepsis. Hemodynamic performance and safety results from the pre-clinical and clinical FIH are very encouraging, and the company is looking forward to continued enrollment in our clinical program with Petr Neužil, M.D., Ph.D., at Na Homolce Hospital in Prague.”
The PercAssist PSCA System technology was showcased at the following TCT24 events:
- TCT Innovation Forum - Interventional Heart Failure: Gerardo Noriega presented the PercAssist PSCA System: Intrapericardial Mechanical Circulatory Support (MCS) System for Cardiogenic Shock
- Mechanical Circulatory Support in PCI: Principal Investigator Professor Petr Neužil, Chairman, Department of Cardiology, Na Homolce Hospital, Prague, CZ, presented the First-in-Human Experience with the Percutaneous Synchronized Cardiac Assist (PSCA) System: Extravascular Mechanical Circulatory Support
Professor Neužil discussed the clinical results from the first five patients enrolled in the EUREKA FIH Study. “The PSCA device was successfully implanted in 5/5 subjects (mean age 74 years; 60% male) with prior resuscitation from cardiac arrest for up to five days.”
Per independent adjudication, no subjects experienced adverse safety events or deaths that were related to the device or procedure. Numerical improvement in left ventricular ejection fraction, cardiac output / index, and mean arterial pressure were noted.
“This FIH experience with SCAI Stage E CS subjects provides encouraging results of the safety and feasibility of the PSCA System breakthrough technology, which does not require vascular access, anticoagulants or contrast, potentially minimizing complications observed with current MCS devices,” continued Professor Neužil. “I am extremely excited to continue our FIH study to evaluate the innovative extravascular PercAssist System in less severe SCAI Stage CS subjects (C and D) in the coming weeks.”
The PercAssist Percutaneous Synchronized Cardiac Assist (PSCA) System is a medical device that enables first-line interventional cardiologists to provide an extravascular / extracardiac solution for patients in need of hemodynamic support for cardiogenic shock. PercAssist is continuing to enroll in its First-in-Human study in Na Homolce Hospital, which will be followed by an expanded Feasibility Study and Pivotal Trial.
About PercAssist, Inc.
PercAssist is a privately held medical device company in Santa Clara, California, founded in 2019 to develop the Percutaneous Synchronized Cardiac Assist (PSCA) System. The PSCA System is designed for extravascular / extracardiac placement to provide hemodynamic support for cardiogenic shock patients without the need for anticoagulant therapy or contrast. Proprietary PercAssist electrocardiogram (ECG) and implant technologies apply left ventricular compression synchronized with the patient’s natural heart rhythm to improve patients’ cardiac output. Longer-term applications for the PSCA System include mechanical circulatory support for heart failure patients. The PSCA System is For Clinical Investigational Use Only and is not for sale in the U.S. or outside the U.S. For more information, visit https://percassist-corp.com.
