Neurescue, a medtech company based in Denmark, created the NEURESCUE system, a balloon catheter designed to occlude the aorta, resulting in a significant increase in blood flow to the heart and brain. The mechanism is intended to provide emergency treatment for patients suffering a hemorrhage or cardiac arrest.
Both hemorrhage and cardiac arrest represent unmet needs, resulting in a significant number of deaths each year. At present only one in ten people survive a cardiac arrest, illustrating the stark outcomes of this patient population.
Aortic occlusion can help to control blood loss and, by increasing blood flow to the heart and brain, the procedure can help to buy some time for patients suffering hemorrhage or cardiac arrest. The device is delivered through the femoral artery, and a safety feedback system helps to ensure that it is correctly placed during temporary balloon inflation. Inflation itself is regulated to prevent overinflation or rupture.
Medgadget had the opportunity to speak with Habib Frost, founder and CEO of Neurescue, about the technology and what it could mean for cardiac arrest outcomes.
Conn Hastings, Medgadget: Please give us an overview of hemorrhage and cardiac arrest, and their consequences for patients.
Habib Frost, Neurescue: Cardiac arrest is the sudden loss of heartbeat in a person and is a major health problem accounting for an estimated 15–20% of all deaths. In the U.S., more than half a million people die each year from cardiac arrest, with only about 1 out of 10 individuals experiencing cardiac arrest outside the hospital surviving to hospital discharge. The numbers are not much higher when the event occurs in the hospital setting, where the survival rate reaches just around 25%. Cardiac arrest is the leading cause of lost life years within heart diseases. 40–50% of all lost life years from heart disease is due to cardiac arrest.
Hemorrhage is severe bleeding, e.g., caused by car accidents, gunshot wounds or pregnancy-related bleedings. Accidents are the leading cause of death for individuals under the age of 45 and hemorrhage accounts for one-third of these deaths. In the U.S. there are 60,000 deaths as a result of hemorrhage per year, and an estimated 1.9 million deaths per year worldwide, 1.5 million of which result from trauma.
Medgadget: How are these conditions currently treated? Why is this suboptimal?
Habib Frost: The current standard of care for cardiac arrest is cardiopulmonary resuscitation (CPR) with chest compressions and defibrillation. Today’s CPR only replaces 35% of blood flow to the heart and the brain, which is not high enough to resuscitate the majority of patients and does not provide enough time to successfully bridge most patients to advanced definitive treatments.
For hemorrhage, ongoing or severe internal bleeding due to e.g., trauma typically requires surgery to correct the problem. When the internal bleeding is severe, emergency surgery needs to take place within minutes. Torso hemorrhage, which cannot be compressed externally, has a survival rate of only 45% because the individual typically bleeds out before definitive surgical treatment can be performed.
Medgadget: What inspired you to develop this technology?
Habib Frost: As a final-year medical student, I witnessed a young girl suffer a cardiac arrest. Despite access to all the available treatments, the physician team was unable to save her life. Later the same day, the team was called to another case of cardiac arrest. This time it was a woman in her 30s. Once again, they were unable to save her life. I felt devastated and in that moment, I knew I wanted to contribute to improving the standard of care for cardiac arrest patients.
Medgadget: Please give us an overview of the NEURESCUE device and how it works.
Habib Frost: The NEURESCUE device is the world’s first intelligent balloon catheter for aortic occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the aorta to redirect blood flow towards the upper body. The procedure is performed to control blood loss or increase perfusion to the heart and brain, and bridge patients to additional life-saving treatment options. The increase in blood flow to the heart and brain, via the temporary aortic occlusion, increases the chance for immediate resuscitation, while also enabling new opportunities to bridge patients to definitive treatment.
The NEURESCUE device consists of a catheter and a control unit, which houses patented sensor guidance and automated inflation technology. The device’s intelligent safety feedback system helps catheter positioning and regulates balloon pressure to prevent over-inflation, rupture, and tissue damage while also monitoring blood pressure. Once deployed, the device supercharges blood flow to the heart and brain within one minute. Its simple design is optimized for emergency situations and through the device’s automated inflation and sensor guidance, the procedure can be performed safely with or without fluoroscopy. This helps enable access to the emergency procedure in the ER and ICU bedsides as well as outside of the hospital.
Here’s a video with more information about the NEURESCUE device and a demonstration of it in use:
Medgadget: How will the device help to improve patient outcomes in hemorrhage and cardiac arrest?
Habib Frost: The NEURESCUE device increases blood flow to the heart and brain, which increases the chance for immediate resuscitation, while also enabling new opportunities to bridge patients to definitive treatment. The NEURESCUE device is complementary to the existing standard of care for cardiac arrest and hemorrhage. The device may bridge patients to receive definitive treatment options, e.g., heart-lung-machine treatment (ECMO), stents (PCI), heart support devices (LVAD), implantable pacemakers or defibrillators, and more. For hemorrhage, the device buys critical time for definitive surgical treatment.
The patented device helps to ensure safe positioning and inflation during CPR or hemorrhage, where fluoroscopy is most often not available. This helps enable the emergency procedure in the ER, ICU, bedside as well as outside of hospitals.
Medgadget: Congratulations on FDA approval of your Investigational Device Exemption application. This will clear the way for a clinical trial of the device in treating cardiac arrest. When, where, and how do you plan to conduct the trial, and if the trial results are positive, what will it mean for the technology and cardiac arrest patients?
Habib Frost: We very much look forward to starting the enrollment of patients in our U.S. clinical trial later this year. This may lead to an expanded indication of the NEURESCUE device as an adjunct for refractory cardiac arrest. When looking at the low survival rate for individuals receiving CPR, it is imperative that novel treatments are given due consideration. There has been little improvement in the outcomes of cardiac arrest over the past decades and we aim for our technology to change this.
Link: Neurescue homepage…