The NEURESCUE device is claimed to be the world’s first intelligent balloon catheter for aortic occlusion
Medical devices maker Neurescue has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its intelligent balloon catheter for aortic occlusion.
NEURESCUE device has been designed for temporary occlusion of large vessels, including patients requiring emergency control of hemorrhage.
The company has also received FDA approval for the investigational device exemption (IDE) application to begin a clinical study of a novel cardiac arrest treatment indication.
The NEURESCUE device is claimed to be the world’s first intelligent balloon catheter for aortic occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment.
Neurescue’s catheter-based device will be inserted through the femoral artery to temporarily inflating a soft balloon in the aorta to redirect blood flow towards the upper body.
The procedure will be carried out to deliver additional time to control blood loss and bridge patients to additional life-saving treatment options, said the company.
Neurescue founder and CEO Dr Habib Frost said: “The FDA 510(k) clearance is an incredible milestone towards achieving our mission, saving the hearts and minds of emergency patients worldwide, giving us market authorisation in the biggest medical device market in the world.
“Additionally, we have received FDA IDE approval to investigate a novel indication for the treatment of cardiac arrest.”
The NEURESCUE device includes a catheter and a control unit, which consists of patented sensor guidance and automated inflation technology.
Its safety feedback system enables to maintain safe catheter positioning and regulate balloon pressure to avoid over-inflation, rupture, and tissue damage while monitoring blood pressure.
The device supercharges blood flow to the heart and brain within one minute, upon its deployment.