Neurescue has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance to market the company’s Neurescue device for temporary occlusion of large vessels, including patients requiring emergency control of haemorrhage. The company also announced the FDA approval of its Investigational Device Exemption (IDE) application to conduct a clinical trial of a novel cardiac arrest treatment indication.
The Neurescue device is an intelligent balloon catheter for aortic occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment, the company said in a press release. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the aorta to redirect blood flow towards the upper body. The procedure is performed to provide additional time to control blood loss and bridge patients to additional life-saving treatment options.
“The Neurescue device represents a significant advancement that could meaningfully improve the survival rates for emergency patients,” said Maham Rahimi, assistant professor of cardiovascular surgery at Weill Cornell School of Medicine, New York, USA. “The device gives patients suffering traumatic blood loss a longer window of time to receive appropriate medical interventions, which can directly translate to saved lives.”