Neurescue announced today that it received CE mark approval for its device designed to treat non-shockable cardiac arrest.
The Copenhagen, Denmark–based company said the milestone “marks one of the most significant advances in resuscitation since the introduction of CPR in 1960.”
According to a news release, every year, an estimated 81% of cardiac arrest patients present as non-shockable. This makes them ineligible for defibrillation. Today, only 4% of these patients survive, the company said.
Neurescue designed its device to directly address this urgent unmet need. The company said CE mark approval makes it the first device of its kind made available anywhere in the world for non-shockable cardiac arrest treatment.
Consisting of a catheter and a handheld control unit, the device temporarily inflates a soft balloon in the descending aorta. This 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.
It restores the patient’s heartbeat and buys time to bridge the patient to interventions like 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, safe procedure.
Neurescue says its device delivered a 100% success rate in clinical trials with just a mean total procedure time of five minutes. It could also offer an option for paramedics and military medics, the company said. The device already has 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 Dr. Habib Frost, 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.”
Neurescue featured on our list of 20 medical device startups you need to know in 2020>>
