NEURESCUE Device Secures Historic CE Mark Approval for Non‑Shockable Cardiac Arrest Treatment

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7:00 AM on Tuesday, September 9

The Associated Press

COPENHAGEN, Denmark--(BUSINESS WIRE)--Sep 9, 2025--

Neurescue ApS today announced CE Mark approval for the NEURESCUE ® device, the first and only medical device approved to treat non-shockable cardiac arrest. Granted by TÜV SÜD after an expedited six-month review under Europe’s Medical Device Regulation (MDR), this milestone marks one of the most significant advances in resuscitation since the introduction of CPR in 1960.

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An estimated 81% of all cardiac arrest patients present as non-shockable, making them ineligible for defibrillation. Today, only 4% of these patients survive. 1 The NEURESCUE device directly addresses this urgent unmet need. With the CE Mark approval, the device becomes the first-of-its-kind available anywhere in the world for non-shockable cardiac arrest treatment, paving the way for international availability.

“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.”

The NEURESCUE device consists of a catheter and a handheld control unit. By temporarily inflating a soft balloon in the descending aorta, it redirects blood flow toward the heart and brain, supercharging circulation to the most critical organs during CPR. The intelligent, fluoroscopy-free device can boost central blood flow within one minute of deployment, thereby restoring the patient’s heartbeat in itself and buying time to bridge the patient to interventions such as a heart-lung-machine, percutaneous ventricular assist devices, and percutaneous coronary intervention. The device features automated inflation and sensor-guided feedback to facilitate a precise and safe procedure from start to finish.

“The NEURESCUE device represents a significant advancement that could meaningfully improve the survival rates for emergency patients,” said Maham Rahimi, M.D., assistant professor of cardiovascular surgery, Weill Cornell School of Medicine, New York.

In clinical trials, all physicians who performed the procedure did so with a 100% success rate and with an only five minutes mean total procedure time. It has also been validated that the device can be used by paramedics and military medics in simulated settings, showing its potential for future broader applicability. In addition to its CE Mark approval in Europe, the NEURESCUE device has received 510(k) clearance for emergency hemorrhage control from the U.S. Food and Drug Administration (FDA).

About Non-shockable Cardiac Arrest

Non-shockable cardiac arrest cannot be treated with defibrillators. To survive a cardiac arrest, a patient must maintain blood flow to both the brain and the heart and achieve a return of spontaneous circulation (a regained heartbeat) or conversion to a shockable rhythm, either of which makes the patient eligible to be bridged to additional therapy.

About Neurescue

Neurescue is a medical device company headquartered in Copenhagen, Denmark, dedicated to saving hearts and minds. The company develops and manufactures cardiovascular solutions to improve outcomes for emergency patients. Its flagship product, the NEURESCUE® device, is the first and only device to receive CE Mark approval in Europe for the treatment of non-shockable cardiac arrest. In the U.S., the device has received FDA 510(k) clearance for emergency hemorrhage control. By increasing blood flow to the brain and heart, the NEURESCUE device helps increase resuscitation rates. The company holds an extensive patent portfolio covering both its current and future products. For more information, visit www.neurescue.com.

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