Time is of the essence in a cardiac emergency, and the ability to restart the heart immediately after a cardiac arrest – even before the arrival of the emergency medical services – markedly increases the chance of survival. However, easy-to-use automated external defibrillators (AEDs) are not always readily available. Avive Solutions, Inc., based in Brisbane, California, near San Francisco, has developed an innovative AED that can alert device owners and bystanders to nearby emergencies, guiding them to the patient to enable more rapid assistance.
Over four million AEDs are currently deployed in the United States, in locations ranging from national fitness chain gyms, resort companies and universities, to police departments and federal government buildings. The market for AEDs is growing at a consistent 10 percent a year, yet survival rates for sudden cardiac arrest (SCA) remain the same despite increased access to these devices. Sameer Jafri, CEO and cofounder of Avive Solutions, Inc., discussed some of the issues contributing to the lack of improvement in survival rates: “AEDs can be situated in any public access setting, from restaurants, coffee shops and shopping malls to large enterprise buildings and airports. If they are deployed quickly, there is a much greater chance of saving the patient’s life; the likelihood of survival decreases by 10 percent for every minute that a defibrillation shock is delayed. These delays can occur for three main reasons. Firstly, a lack of access; there may be numerous AEDs nearby, but nobody knows where they are. Secondly, untrained bystanders generally find it intimidating to pick up and use a seemingly complex medical device. Finally, most AEDs lack connectivity, meaning that the only way to be sure that a device is functional is to physically inspect it; checking functionality remotely is not an option. That is a major challenge for large organizations deploying tens, or even hundreds, of AEDs across multiple sites, and can become so burdensome that proper maintenance does not happen, risking that devices are not functional when required.”
Information is key to survival in a cardiac emergency, and lack of connectivity also makes it difficult for local AEDs to be integrated into the emergency response system. Sameer continued: “When a 911 call is made to the emergency services, the call handler will ask if an AED is available, and it is often the case that the caller will not know. Even if an AED is located and used on the patient before the emergency services arrive on the scene, the person usually arrives at the hospital without an ECG recording from the AED. This forces clinical decision-making without critical incident information from before the arrival of the emergency services. A more connected system of response is essential, and so we developed the Avive Connect AED®.”
The Avive Connect AED is a small, lightweight device designed to be easy to use and highly portable, with a rechargeable battery to avoid the need for costly routine replacement of traditional batteries. Crucially, it offers advanced connectivity that enables straightforward, automated maintenance checks and integration into the 911 emergency call system. When enabled, its revolutionary QuickRescue™ feature – launched in October 2024 – triggers an automatic notification to 911 once the AED’s electrode pads have been placed on the patient and the initial rhythm analysis completed. Emergency communication centers are advised of the device’s location and event details, which are then shared with first responders to provide them with critical information about the patient’s condition before they arrive on scene.
Sameer explained: “The Avive Connect AED is extremely compact and weighs just over two pounds (950 grams), making it highly portable. Importantly, it offers full connectivity with cellular, Wi-Fi, GPS and Bluetooth technologies. Data from each device can be accessed and stored in our REALConnect Platform™ asset tracking and fleet management software, which displays the status of the customer’s entire AED fleet. This means that customers can know where their devices are, that they’re functional, if they’re in use and more, eliminating the need for routine physical inspections. More importantly, the devices can be integrated into 911 call centers using Intelligent Response™ software. In the event of a suspected cardiac arrest, the call handler can activate an audible alert on Avive Connect AEDs nearby to the location of the emergency. Once a person has accepted that alert on the AED, the device will display a map showing the location of the patient and how to navigate to the scene of the emergency. The call center is then able to see the location of the device as the person moves towards the site of the emergency, monitor its use to see whether the patient is in a shockable rhythm, and register how many shocks have been delivered. This information can be passed to the emergency services on arrival, and transferred via the cloud to the hospital cardiologist or emergency department, ensuring access to the patient’s pre-hospital history.”
Avive began the search for a contract manufacturer for the Avive Connect AED in 2019, and chose to partner with Paramit®, Tecan’s contract manufacturing services business. “We spoke to several contract manufacturers before choosing Paramit,” said Sameer. “We wanted a manufacturer that would partner with us in the later stage of the development phase, and chose Paramit for several reasons, the main one being its focus on medical devices. These devices must adhere to strict quality standards, and Paramit is unparalleled in this regard. The company’s new product introduction team understood our concept from day one, so the onboarding time was short, and the customer service was incredible. There was also a strong desire from both parties to work together, and we had access to the highest levels of the company, meeting with the executive leadership early in the process.”
“We applied ‘Design for Manufacturing’ principles to optimize the product design, then the AED was manufactured using Paramit’s vPoke® computer-directed assembly technology. At the same time, we were able to draw on Tecan’s expertise in preparing for FDA regulatory audits, which was invaluable. As a result, we received FDA approval in the fall of 2022, and have been manufacturing and shipping devices for more than 15 months now, which has already led to many lives being saved in the field. Tecan and its contract manufacturing team at Paramit are great partners for us: it is truly a symbiotic relationship,” Sameer concluded.
For research use only. Not for use in clinical diagnostics.