BrioHealth obtains FDA nod to trial BrioVAD ventricular assist device

BrioHealth Solutions has received FDA approval for its BrioVAD system under an investigational device exemption (IDE). The company aims to assess the BrioVAD's efficacy and safety in treating refractory left ventricular heart failure in the Innovate trial, with clinical site start-up activities already underway in the US.

The BrioVAD system comprises a blood pump with a magnetically levitated rotor and two small, patient-worn components, aiding blood circulation in heart failure patients.

The Innovate trial will evaluate short-term (six-month) and long-term (24-month) performance, comparing it with FDA-approved technology.

GlobalData projects the cardiovascular device market to reach $86.5 billion by 2030, with left ventricular assist devices reaching $2.24 billion by 2033. Abbott's HeartMate 3 leads the market, although it faced a Class I recall in March 2024.

Advancements continue, with Magenta Medical's Elevate and MagAssist's NyokAssist offering promising alternatives to traditional ventricular assist devices.