BrioHealth wins FDA nod to trial BrioVAD ventricular assist device [Yahoo! Finance]
Abbott Laboratories (ABT)
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Source: Yahoo! Finance
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. 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.
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