Neurescue has announced CE mark approval for the Neurescue device to treat non-shockable cardiac arrest.
The device consists of a catheter and a handheld control unit, whereby a soft balloon is inflated in the descending aorta in order to redirect blood flow toward the heart and brain, supercharging circulation to the most critical organs during CPR.
The 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 (PCI), the company says in a press release. The device features automated inflation and sensor-guided feedback to facilitate a precise and safe procedure.
“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, founder and chief executive officer 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 represents a significant advancement that could meaningfully improve the survival rates for emergency patients,” said Maham Rahimi, assistant professor of cardiovascular surgery, Weill Cornell School of Medicine (New York, USA).
In clinical trials, all physicians who performed the procedure did so with a 100% success rate and with an only five minute 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 haemorrhage control from the US Food and Drug Administration (FDA).
