PercAssist, Inc., a medical device company developing extravascular biventricular mechanical circulatory support technology, has announced the successful enrolment of the first patient in its AVANXA Clinical Feasibility Study in São Paulo, Brazil.

The study is evaluating the PercAssist eVAD™ System in patients with cardiogenic shock (CS). The first patient had SCAI Stage D cardiogenic shock and received support from the system for two and a half days, with reported improvements in haemodynamic performance.

The PercAssist eVAD System uses an extravascular, intrapericardial balloon implant and does not require access to large blood vessels. The company says this approach is designed to reduce complications associated with conventional mechanical circulatory support devices, including major bleeding, haemolysis and limb ischaemia.

The first patient was recovering from an ST-elevation myocardial infarction (STEMI) and experienced SCAI Stage D cardiogenic shock. Following implantation, blood pressure returned to normal levels and the need for vasopressor medication decreased.

The system is designed to provide haemodynamic support without vascular access, anticoagulants or contrast. These features could help reduce some of the complications associated with existing mechanical circulatory support technologies.

PercAssist is continuing patient enrolment in the AVANXA feasibility study in São Paulo. The company plans to follow the study with an Investigational Device Exemption (IDE) study in the US.

The eVAD System is being developed as an extravascular option for interventional cardiologists to provide mechanical circulatory support to patients experiencing cardiogenic shock.

 

Source: businesswire.com

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