Not all cardiac arrests can be treated with an electric shock. In fact, most of them—about 80%—are ineligible for defibrillation. With a survival rate of about 4%, these deaths continue to number between 7 million and 9 million per year.
Neurescue has been working for over a decade to develop an easy-to-use system capable of directing oxygenated blood to the heart and brain when it’s needed most. Now, the former Fierce Medtech Fierce 15 winner has received a European approval for its smart balloon catheter, marking a major addition to the field of resuscitation.
“For the first time, we now have a device for the vast majority of cardiac arrest patients who present as non-shockable,” Neurescue founder and CEO Habib Frost, M.D., said in a statement. “This is a breakthrough approval for millions of cardiac arrest patients annually.”
“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,” Frost said.
In order to survive a non-shockable cardiac arrest, a patient must maintain blood flow to the brain and the heart until their heart rhythm returns to normal or converts to one that can be defibrillated. CPR chest compressions aim to buy time, but they can only replace about a third of the heart’s typical pumping action, and survival rates remain low even in optimal hospital conditions.
Neurescue’s device is designed to act in an average of five minutes. With a catheter and handheld control unit, it can be inserted into the thigh’s femoral artery and threaded up into the lower aorta, where it automatically inflates a soft balloon without the need for any X-ray imaging.
This blocks the flow of blood to the lower limbs, forcing oxygen back into the heart and up to the brain and improving the effects of CPR, while giving clinicians the opportunity to employ additional life support devices.
Balloon occlusion procedures such as this have often been performed within operating rooms and cath labs, under real-time fluoroscopy guidance to help stop severe bleeding. The Neurescue system aims to operate anywhere—using embedded sensors that measure changes in blood pressure to help track its position as it moves and deploys into larger vessels.
The device previously received a clearance from the FDA for use in emergency hemorrhage control.