Neurescue Gains CE Mark for Non‑Shockable Cardiac Arrest Device

Neurescue has received CE mark approval for the Neurescue device to treat non-shockable cardiac arrest. According to the company, it’s the first medical device approved for this indication.

The device consists of a catheter and handheld control unit. It temporarily inflates a soft balloon in the descending aorta, redirecting blood flow toward the heart and brain and supercharging circulation to the most critical organs during CPR.

The intelligent, fluoroscopy-free device can enhance central blood flow within one minute of deployment, restoring the heartbeat in itself and buying time to bridge the patient to interventions like a heart-lung-machine, percutaneous ventricular assist devices, and percutaneous coronary intervention.

It also touts automated inflation and sensor-guided feedback to facilitate a precise, safe procedure.

Neurescue said physicians performing the procedure had a 100% success rate with five minutes of mean procedure time. It’s also been validated that paramedics and military medics can use the device in simulated settings.

The device has also earned U.S. Food and Drug Administration (FDA) 510(k) clearance for emergency hemorrhage control.

“For the first time, we now have a device for the vast majority of cardiac arrest patients who present as non-shockable. This is a breakthrough approval for millions of cardiac arrest patients annually,” said Habib Frost, M.D., founder and CEO of Neurescue. “This CE Mark approval is more than a regulatory milestone. It bridges a gap for millions of patients facing the most critical life-threatening condition.”