Future Hub to the FDA: Following HeartHero's Journey Since the ACC.19 Innovation Challenge Win

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HeartHero claimed victory on the Future Hub stage at ACC.19 in New Orleans for the most innovative medical device. Now, they are working to bring Elliot – a "smart" automated external defibrillator (AED) to market.

In just a year, the Denver-based company now has a pending CE mark from the European Union (EU) and U.S. Food and Drug Administration (FDA) approval in the pipeline.

Elliot and the HeartHero team started this year in the national spotlight, with its selection as one of ABC television's "Top Gadgets from CES 2020." The smart AED was showcased at the Consumer Electronic Show (CES) in Las Vegas, held annually by the Consumer Technology Association (CTA).

In February, the ACC announced a collaboration with HeartHero around its innovative and miniaturized AED, which has the potential to make a significant impact on survival rates after sudden cardiac arrest (SCA).

"While CPR has been the tool that buys us time in cardiac arrest, it's clear that electricity is the medicine that saves your life," says Gary Montague, CEO and founder of HeartHero.

Increasing awareness around the importance of AEDs and placing them into the homes of persons at higher risk of SCA are the driving passions behind HeartHero's mission. "Our exclusive relationship with the ACC is monumental in our goal of saving more lives," says Montague.

"With current technology and data, we're able to advance the AED industry with the ambition of making the greatest impact to cardiac arrest survivability seen in our time. Our relationship with the ACC will help pave the way for this outcome through research that studies and identifies those at risk and ultimately getting AEDs placed where they need to be," he adds.

With the collaboration, an ACC Member Work Group was formed, chaired by Ami Bhatt, MD, FACC. She's working with fellow members Nisha Chandra-Strobos, Rohan Goswami, MD, Jennifer Monti, MD, and Jordan Strom, MD, Msc, FACC, to provide ongoing clinical guidance to HeartHero.

"AEDs save lives, but despite their increasing presence in buildings and public spaces, there is no way to guarantee quick enough access to one in cases of sudden cardiac arrest," says John Rumsfeld, MD, PhD, FACC, ACC chief science and quality officer and chief innovation officer.

"The ACC recognizes the lifesaving potential for innovative AEDs and is eager to work with HeartHero in making them widely known in the cardiovascular community and widely available to the public."

HeartHero's AED is unlike other AEDs on the market. Using cutting-edge technology and advanced machine learning, HeartHero's AED will progress the external defibrillator industry. The AED's intelligent AI rhythm detection far exceeds the guidelines set by the American Heart Association.

HeartHero submitted their document packet for CE Mark approval from the EU in early March, and it's under review by a Notifying Body. The stamp of approval will allow HeartHero to begin sales of Elliot in Europe and several other countries around the world. HeartHero is currently working on their FDA submission that will be completed in 2020.

Upon CE Mark and FDA approval, HeartHero is ready to bring Elliot to market. In the COVID-19 era, it has never been more important to empower individuals with a home defibrillator so they can have a fighting chance against SCA.

HeartHero also looks to partner with cardiologists to send at-risk patients home with an AED, made possible with their connection to the ACC. HeartHero is ambitious in their goal of advancing the AED industry and making the greatest impact to SCA survivability.

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Clinical Topics: Arrhythmias and Clinical EP, COVID-19 Hub, Implantable Devices, SCD/Ventricular Arrhythmias

Keywords: ACC Publications, Cardiology Magazine, American Heart Association, United States Food and Drug Administration, Survival Rate, severe acute respiratory syndrome coronavirus 2, COVID-19, Cardiopulmonary Resuscitation, Heart Arrest, Industry, Death, Sudden, Cardiac, Defibrillators, Goals, Innovation

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