Neurescue’s Intelligent Balloon Catheter Cleared by FDA for Hemorrhage Control

June 10, 2021—Neurescue, a Denmark-based developer of cardiovascular solutions to improve the outcomes for emergency patients, announced that the 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 hemorrhage.

Additionally, the company received FDA approval of its investigational device exemption (IDE) application to conduct a clinical trial of a novel cardiac arrest treatment indication.

According to the company, the Neurescue device is an “intelligent” balloon catheter for aortic occlusion, an emergency technique that supercharges blood flow to the heart and brain within 1 minute from deployment. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the aorta to redirect blood flow toward 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 device consists of a catheter and a control unit, which houses the company’s sensor guidance and automated inflation technology. The device’s intelligent safety feedback system helps ensure safe catheter positioning and regulates balloon pressure to prevent overinflation, rupture, and tissue damage while also monitoring blood pressure, noted the Neurescue announcement.

“The Neurescue device represents a significant advancement that could meaningfully improve the survival rates for emergency patients,” commented Maham Rahimi, MD, in the company’s press release. “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.” Dr. Rahimi is Assistant Professor of Cardiovascular Surgery at Weill Cornell School of Medicine in New York, New York.