PercAssist enrolls first patient in feasibility study for cardiogenic shock device

PercAssist, Inc., a Santa Clara, California-based medical device company developing extravascular biventricular mechanical circulatory support technology, announced that the first patient has been enrolled in its AVANXA Feasibility Study, with the procedure successfully conducted in São Paulo, Brazil.

The patient presented with Society for Cardiovascular Angiography and Interventions (SCAI) Stage D cardiogenic shock, a classification denoting a deteriorating patient with limited treatment options. According to the company, the PercAssist eVAD System supported the patient's hemodynamic recovery over a two-and-a-half-day period. The device is an extravascular, intrapericardial balloon implant that PercAssist says requires no large vessel access, distinguishing it from many existing mechanical circulatory support (MCS) options.

"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."

Noriega added that PercAssist is looking forward to continued enrollment in its 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.

Campos, who treated the first enrolled patient, described the procedure and early results. "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," he said. "The patient's blood pressures normalized, and the use of vasopressors have diminished."

Campos said the case supports the broader premise behind the device's design. "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 mechanical circulatory support devices," he said. "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 designed to give first-line interventional cardiologists an extravascular option for delivering hemodynamic support to patients in cardiogenic shock. The company said it will continue enrolling patients in the São Paulo feasibility study before advancing to a U.S. Investigational Device Exemption (IDE) study.

Current standard-of-care MCS devices for cardiogenic shock, including several percutaneous options, typically require large-vessel vascular access and carry risks such as major bleeding, hemolysis and limb ischemia. PercAssist's extravascular approach is intended to sidestep those risks by avoiding vascular access altogether, while also eliminating the need for anticoagulants or contrast media during the procedure, according to the company. Improving hemodynamic assessment and support without invasive vascular routes has been a broader focus among device developers working in heart failure and cardiogenic shock.

PercAssist is a privately held medical device company based in Santa Clara, California, founded to develop the eVAD System. The system is designed for extravascular placement to provide hemodynamic support for cardiogenic shock patients while avoiding complications such as major bleeding, hemolysis and limb ischemia. The company's proprietary implant technologies apply biventricular compression synchronized with a patient's natural heart rhythm to improve ejection fraction and cardiac output. PercAssist said 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 currently for sale in the U.S. or elsewhere.