FDA Clears Neurescue’s Intelligent Balloon Catheter

Neurescue has received FDA 510(k) clearance for its Neurescue intelligent balloon catheter, allowing the device’s use for temporarily occluding large vessels in patients who require emergency hemorrhage control.

According to Neurescue, the device is the world’s first intelligent balloon catheter for aortic occlusion, an emergency technique that dramatically increases blood flow to the heart and brain within a minute of deployment.

The catheter-based device is delivered through the femoral artery, temporarily inflating a soft balloon in the aorta to redirect blood flow toward the upper body.