Shocked into action to prevent sudden cardiac arrest fatalities

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.

The Avive Connect AED^®—developed by California-based Avive Solutions, Inc., and manufactured by Tecan’s Paramit^® contract manufacturing business—is designed to address this challenge, guiding device owners and bystanders to nearby emergencies to enable more rapid assistance.

Introduction

There are over four million AEDs currently deployed across the United States (US), and these devices are becoming increasingly common in locations ranging from national fitness chain gyms and resorts to universities, police departments, and federal government buildings. Despite this trend, which is seeing the market for AEDs growing at a consistent 10 percent a year, the survival rates for sudden cardiac arrest (SCA) remain almost unchanged year on year.

Sameer Jafri, CEO and co-founder of Avive Solutions, has outlined 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 a patient’s life; the likelihood of survival decreases by 10 percent for every minute that a defibrillation shock is delayed.

Sameer Jafri, CEO and Co-Founder of Avive Solutions

Delays in AED deployment can occur for three main reasons. First, there may be multiple AEDs near an incident, but no one knows their locations. Second, untrained bystanders often hesitate to use what appears to be a complex medical device. Finally, most AEDs are not connected to a monitoring system, so their functionality can only be confirmed through physical inspection. This makes maintenance more burdensome and increases the risk of inconsistent device performance.

Directing Care to Where it’s Needed

Avive Solutions was founded to address these issues by creating a revolutionary AED that can integrate into existing emergency response systems, meeting the needs of patients, end-users and emergency service coordinators.

Sameer explained: “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 extremely compact and weighs just over 950 grams (just two pounds), making it highly portable. Crucially, it offers advanced connectivity with cellular, Wi-Fi, GPS, and Bluetooth technologies, allowing devices to 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 near the emergency location. Once a person has accepted that alert on the AED, the device will display a map and navigate them to the location of the patient. The call center is also able to monitor the location of the device in real time, see whether the patient is in a shockable rhythm, and register how many shocks have been delivered.

Alternatively, if the Avive Connect AED is deployed before an emergency call has been made, its QuickRescue^™ feature automatically notifies 911 once the electrode pads are placed on the patient and the initial rhythm analysis is complete. Emergency communication centers receive the device’s location and event details, which are then shared with first responders to give them critical information about the patient’s condition before they arrive. This data can also be transferred via the cloud to the hospital’s cardiologist or emergency department, ensuring they have access to the patient’s pre-hospital history.

Designed and Manufactured for Reliability

Maintaining a network of AEDs in working order can be a significant cost and time burden, especially for government departments or large enterprises.

The Avive Connect AED is equipped with a rechargeable battery, eliminating the need for costly routine replacement of traditional batteries, and can perform simple, automated maintenance checks. Data from each device is uploaded to the REALConnect Platform^™ fleet management software, which displays the status of an organization’s entire AED fleet. This allows device owners to know where their devices are, confirm they are functional, and see if they are in use, removing the need for routine physical inspections.

Reliability is obviously a critical consideration for any life-saving equipment, so Avive Solutions carefully assessed potential manufacturing partners before beginning production.

We spoke to several contract manufacturers before choosing Paramit. 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.

Sameer Jafri, CEO and Co-Founder of Avive Solutions

The product design was optimized using ‘Design for Manufacturing’ principles, then the AED was manufactured using the Paramit vPoke^® computer-directed assembly technology. Avive Solutions was also able to draw on Tecan’s expertise in preparing for FDA regulatory audits, helping to accelerate approvals and get the system to market sooner.

“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.

About Tecan

​Tecan is a leading global provider of automated laboratory instruments and solutions. Its systems and components help people working in clinical diagnostics, basic and translational research, and drug discovery bring their science to life.

In particular, the company develops, produces, markets and supports automated workflow solutions that empower laboratories to achieve more. Its Cavro^® branded instrument components are chosen by leading instrumentation suppliers across multiple disciplines.

Tecan works side by side with a range of clients, including diagnostic laboratories, pharmaceutical and biotechnology companies and university research centers. Its expertise extends to developing and manufacturing OEM instruments and components, marketed by its partner companies. Whatever the project – large or small, simple or complex – helping its clients to achieve their goals comes first.

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