PercAssist, Inc., a medical device company developing innovative technology for extravascular Biventricular Mechanical Circulatory Support to provide hemodynamic improvements for patients in cardiogenic shock (CS), today announced the first patient enrollment for the AVANXA Feasibility Study was successfully conducted in São Paulo, Brazil.

“I am thrilled to share the successful clinical use of the PercAssist eVAD System in a patient with SCAI Stage D CS,” said Gerardo Noriega, president and CEO of PercAssist. “The patient had limited CS treatment options, and the PercAssist eVAD System provided the needed support to aid in hemodynamic recovery over a two and a half-day period. 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 and limb ischemia. PercAssist is looking forward to continued enrollment in our clinical program with Alexandre Abizaid, M.D., Ph.D., Carlos Campos, M.D., Ph.D., and Roger Renault Godinho, M.D., Ph.D., in São Paulo, Brazil.”

Dr. Campos discussed the clinical results from the first patient enrolled in the AVANXA Study. “The eVAD device was easily implanted in minutes in a patient recovering from STEMI with SCAI Stage D CS with noted improvements in hemodynamic performance. The patient’s blood pressures normalized, and the use of vasopressors have diminished.”

“This early feasibility experience with a SCAI Stage D CS subject provides encouraging results of the feasibility of the PercAssist eVAD System breakthrough technology, which does not require vascular access, anticoagulants or contrast, potentially minimizing complications observed with current MCS devices,” continued Dr. Campos. “I am extremely excited to continue our early feasibility study to evaluate the innovative PercAssist eVAD System in less severe SCAI Stage CS subjects (C and D) in the coming weeks in São Paulo, Brazil.”

The PercAssist eVAD System is a medical device that enables first-line interventional cardiologists to provide an extravascular solution for patients in need of hemodynamic support for CS. PercAssist is continuing to enroll in the feasibility study in São Paulo, which will be followed by a US IDE Study.

About PercAssist, Inc.

PercAssist is a privately held medical device company in Santa Clara, California, founded to develop the eVAD System. The eVAD System is designed for extravascular placement to provide hemodynamic support for cardiogenic shock patients avoiding complications such as major bleeding, hemolysis or limb ischemia. Proprietary PercAssist implant technologies apply biventricular compression synchronized with the patient’s natural heart rhythm to improve ejection fraction and cardiac output. Longer-term applications for the eVAD System include mechanical circulatory support for heart failure patients. The eVAD 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.

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