The Innovate trial will assess the BrioVAD system performance both in the short term, with a six-month endpoint, and in the long term over 24 months. Image Credit: Emily frost / Shutterstock.

BrioHealth Solutions has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its BrioVAD system.

Following the approval, the company plans to test the efficacy and safety of the BrioVAD system as a treatment for refractory left ventricular heart failure in the Innovate trial. BrioHealth said it has started clinical site start-up activities in the US.

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The BrioVAD system consists of a haemocompatible blood pump along with a fully magnetically levitated rotor and two small, lightweight, patient-worn components. The device compensates for heart failure by helping pump blood from the lower chambers of the heart to the rest of the body.

The Innovate trial will assess the system performance both in the short term, with a six-month endpoint, and in the long term over 24 months. BrioHealth did not provide many details on the trial design but stated that it plans to compare the device to “technology previously approved by the FDA”.

GlobalData predicts the cardiovascular medical device market will reach $86.5bn by 2030. The left ventricular assist device market segment will reach $2.24bn by 2033. Abbott’s HeartMate 3 is the current market leader in the field and was approved by the FDA for less invasive implantation using lateral thoracotomy in 2020.

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In March, Abbott suffered a setback when it was forced to issue a Class I recall of the HeartMate Touch System. The recall involved more than 1,500 devices in the US distributed between May 2020 and January 2024 and followed eight reported injuries, three of which occurred during surgery.

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There have been multiple advancements in the field of left ventricular assist devices. Magenta Medical is developing the ‘world’s smallest heart pump’, Elevate. In August 2023, the company completed enrolment in an early feasibility study for the device.

The same month, MagAssist received a breakthrough device designation from the FDA for its NyokAssist interventional ventricular assist device. Unlike traditional ventricular assist devices, NyokAssist’s motor sits outside the body to minimise access size of the device allowing for device implantation without requiring open-heart surgery.