AEDs drive the defibrillator market and yet…

The AED segment is finally seeing traction. The so-many-years-of-push began to translate to installations in 2023. Yet, experts indicate that the product is only being used by less than 1 percent of people. A dichotomy indeed!

The year 2023 may be defined as the year of turnaround for AEDs. Over the past few years, there has been a big push to get automated external defibrillators (AEDs) installed in public spaces to help save lives threatened by cardiac arrest. And 2023 saw the market gain traction.

The Indian AED market saw sales jump from ₹28 crore, at 3850 units in 2022 to ₹36 crore at 6000 units in 2023, a 29 percent jump in value. Airports, community centers, schools, government buildings, and other public locations are now emphasizing the installation of defibrillators. Its global counterpart, at USD 1.8 billion, is poised at an 8.6-percent CAGR.

And the trend is expected to continue. The increasing number of supportive policies by governments, regulatory bodies, and healthcare organizations is anticipated to fuel growth. The Italian Resuscitation Council reported that the Social Affairs Commission of the Chamber approved the proposed law on AEDs in Italy. The law provides for about 10 million EUR (about USD 11.36 million) for implementing public access AEDs over the next five years, among other provisions. In Australia, the government agency SA Ambulance Service recommends using a defibrillator as early as possible to increase the person’s chances of survival. Both semi-automatic and automatic AEDs are recommended, while manual defibrillators are recommended for use by trained professionals only. Due to their ease of use, AEDs are recommended over a manual defibrillator in low acuity settings, including medical and allied health and dental clinics.

Also, the growing initiatives by major companies are increasing the adoption of defibrillators at healthcare facilities and deploying several public access defibrillation programs. For instance, in March 2024, Schiller introduced the FRED easy G2, its new AED. CE-certified by MDR, it is designed for basic and advanced life support. It guides the rescuer through all the interventions. The device is compact, lightweight, smart, and ready for action, and perfectly complements every emergency kit. It offers mobility and flexibility in a time-critical situation.

Developing lightweight and compact devices has improved portability for public access use. Falling device prices also support the procurement of external defibrillators for placement in offices, sports facilities, transportation hubs, and other public areas.

The dichotomy is that, finally, having gained acceptance, the devices are not being used. Research presented at the American College of Cardiology’s Annual Scientific Session in Chicago in March 2024 said that AEDs were only used in 13 of nearly 1800 cases of out-of-hospital cardiac arrest, even though many of the incidents occurred near a public AED.

New research presented at the British Cardiovascular Society Conference in Manchester supports this. It affirmed that defibrillators are used in only one out of every ten cardiac arrests where lifesaving devices are available. The study used the East of England Ambulance Service and The Circuit, the British Heart Foundation’s (BHF) national defibrillator network.

Whereas in the West, the survival rate from sudden cardiac arrests has gone up by 60–70 percent, in India, it continues to be a dismal 1 percent, say experts associated with a recent Lancet study on sudden cardiac deaths (SCD).

“As such, SCDs aren’t a new problem in India, but the country is now facing a sharply increasing burden of sudden cardiac arrests and eventual deaths. A rough estimate, which might be an underestimate, shows that annually, around 500,000–600,000 people are dying due to sudden cardiac deaths in India. Western nations have enough infrastructure to widely disseminate the training of CPR and AEDs to the common public. We don’t have that level of awareness and policies, and that is why communities must be partners in responding to sudden cardiac arrests,” says Dr Kumar Narayanan, Senior Consultant Cardiologist, Electrophysiologist, and Deputy Chair of The Lancet SCD Commission.

“AEDs save lives. A person’s chance of surviving drops by seven to 10 percent every minute a normal heartbeat isn’t restored. So, immediate CPR and AED use can double or triple the person’s chance of survival. AEDs are intended for use by the general public (lay responders) and can make a difference at hotels, playgrounds, shopping malls, and other public places. Usually, non-medical personnel, such as police, firefighters, flight attendants, and security guards, are trained to use AEDs,” said Dr Dnyaneshwar Shelke, Chief Operating Officer, BVG- Maharashtra Emergency Medical Services.

The total Indian defibrillators market is estimated at ₹290 crore and 17,250 units in 2023. Apart from the AEDS, the monophasic segment continues to command a 40–43 percent share by numbers. Despite being catered to by a handful of organized players and the balance by regional brands, it holds sway on a specific customer segment. The biphasic defibrillators market in 2023 remained almost stagnant despite providing a higher success rate of cardioversion with less energy delivered.

The global defibrillators market is estimated to reach USD 20.1 billion by 2031, up from USD 12.7 billion in 2024, growing at a CAGR of 6.8 percent. External defibrillators have 61.8 percent of the market share in 2024.

The emergency nature and acute management of cardiac emergencies demand quick accessibility to defibrillators within the hospital infrastructure. Defibrillators are regularly used in intensive care units, cardiac catheterization labs, cardiac surgery suites, and emergency rooms where the monitoring and treatment of arrhythmias are frequently needed.

Moreover, rising healthcare spending on quality of care and new hospital infrastructure development in developing countries are also driving the growth of the hospital segment. Stringent guidelines regarding defibrillator availability in all hospital departments and areas further boost hospital procurement.

Within the region, North America has been the largest and most dominant regional market for defibrillators globally and holds 42.9 percent of the market share in 2024. The area enjoys a strong presence of major industry players with huge investments in R&D and manufacturing facilities.

The Asia-Pacific region, especially China and India, has emerged as the fastest-growing region in recent years. Rising medical needs due to large populations and improving economic conditions are driving heavier investments in healthcare infrastructure and services across developing nations. This has boosted the demand for defibrillators in hospitals, public access points, and community centers.

At the same time, the region is witnessing steady growth in medical devices manufacturing, with emerging multinational players setting up production bases to cater to the local and export markets. The low production costs have made Asia-Pacific an attractive sourcing destination for defibrillator devices globally and boosted its exports.

However, due to minimal IP protection and price-sensitive end users in some nations, the average selling prices of devices are relatively lower compared to developed markets.

Monophasic and biphasic defibrillators represent critical advancements in medical technology, particularly in cardiac emergency management. Monophasic defibrillators deliver electrical shocks in a single direction, necessitating higher energy levels for effective treatment. This higher energy consumption, while effective, poses risks such as tissue damage and adverse effects like burns. Despite their historical affordability, they are gradually being superseded by biphasic defibrillators due to their superior safety profile and efficacy.

In contrast, biphasic defibrillators administer shocks in two directions, utilizing lower energy levels more efficiently. This bidirectional waveform enhances safety by reducing the risk of complications and tissue damage and improves overall patient outcomes. These devices are favored in modern healthcare settings for their versatility across various cardiac conditions and patient demographics.

The evolution of biphasic technology has been instrumental in saving lives, particularly highlighted during the pandemic when efficient cardiac care was paramount. Their reduced side effects and enhanced effectiveness make them a preferred choice for medical professionals worldwide. Regulatory bodies increasingly endorse biphasic defibrillators, aligning with current medical guidelines and recommendations. While initially a higher investment, the potential benefits of patient outcomes justify their adoption in contemporary medical practices.

Developing a low-cost, portable, disposable defibrillator represents a crucial advancement in managing sudden cardiac arrest, especially in regions with limited access to medical facilities. Current statistics show high mortality rates, particularly outside Western countries, due to delays in accessing defibrillation. The proposed solution addresses these challenges by offering a compact, user-friendly device that delivers biphasic shocks, tailored to pediatric and adult patients (50–150 Joules). This innovation includes ECG monitoring and can administer up to six shocks with stored energy, ensuring safety and efficacy even in the hands of untrained individuals.

Tested for accuracy and safety in a clinical engineering setting, achieving a high accuracy rate of 98.03 percent, the device meets industry standards for shock energy, release time, and waveform. Weighing just 1.3 kg and sized like a notebook, its portability enhances accessibility, while potential future integration with wireless IoT technology could further streamline operations. This initiative aims to democratize access to life-saving technology, potentially transforming outcomes for cardiac arrest victims globally by facilitating early defibrillation and improving survival rates beyond the limitations of current healthcare infrastructures.

The evolution of implantable cardioverter defibrillators (ICDs) has seen significant technological advancements since their inception in the 1980s. Initially designed to detect and treat ventricular fibrillation with high-energy shocks, early ICDs were limited in managing unstable ventricular tachycardias. Over time, new generations of devices introduced features like anti-tachycardia pacing (ATP), telemetry, and programmability, using more efficient battery technologies to extend lifespan and reduce maintenance.

ICDs are critical for managing severe cardiac arrhythmias, such as ventricular tachycardia and fibrillation, and they serve as a preventive measure in patients at high risk of sudden cardiac death. These devices are also indicated in particular heart failure cases and for patients with specific cardiac conditions or histories determined through a thorough medical evaluation.

Advancements in ICD technology include the transition from epicardial to transvenous leads, which improved safety and reduced complications associated with lead placement. Further innovations focus on miniaturization, battery longevity, and enhancing lead technologies to minimize risks, such as lead failure and infections. Subcutaneous ICDs offer an alternative in patients with challenging venous access, though current limitations exclude them from treating bradycardia or certain arrhythmias.

Future developments in ICDs aim to integrate artificial intelligence for better arrhythmia detection and personalized therapy adjustments. Leadless ICDs represent a growing trend due to their potential to simplify implantation and reduce associated complications. Telemonitoring capabilities enhance remote patient management and early intervention, promising further advancements in cardiac care.

Recent advancements in technology
In the world of emergency medical response, every second counts. When a sudden cardiac arrest (SCA) occurs, immediate action is crucial to increase the chances of survival. Defibrillators have long been hailed as life-saving devices, but recent technological advancements have introduced a dynamic duo that can potentially save even more lives.

Pairing defibrillators with automated CPR devices. Michigan Instruments has pioneered automated CPR devices for over 50 years, exemplified by their Life-Stat, which adheres to AHA guidelines for compressions and ventilation. These devices are renowned for their lightweight design, ease of use, and versatility. One of their key advantages is maintaining uninterrupted chest compressions even while defibrillators are applied, ensuring continuous support during resuscitation efforts. Michigan Instruments’ automated CPR machines offer consistent and adjustable compressions, which are crucial for optimizing blood circulation and oxygen delivery to vital organs. They excel in challenging environments, such as moving vehicles or confined spaces, where manual CPR may be impractical or hazardous. Studies affirm that the combination of automated CPR and defibrillation significantly improves survival rates for individuals experiencing sudden cardiac arrest (SCA). This synergy underscores their vital role in emergency response, providing healthcare professionals with reliable tools to enhance patient outcomes in critical situations.

Double sequential external defibrillation (DSED). A new procedure for cardiac arrest patients, DSED, involves using two defibrillators to deliver rapid sequential shocks, potentially improving survival rates for patients with ventricular fibrillation or pulseless ventricular tachycardia, who do not respond to standard defibrillation. Traditional defibrillation positions pads on the chest and armpit, delivering shocks every two minutes. However, 20 percent of patients with these specific heart conditions do not respond to this method. DSED places pads in two locations, allowing for two sequential shocks, which can eliminate persistent abnormal electrical activity more effectively.

A recent trial showed that DSED more than doubled survival rates compared to standard resuscitation methods, prompting New Zealand to update its clinical guidelines. Emergency medical personnel now receive training in DSED, and the procedure is applied if two standard defibrillation shocks fail. Implementation includes mandatory education, simulation, and close monitoring to ensure patient safety and effectiveness. Initial data indicates that DSED could significantly improve outcomes for cardiac arrest patients, with an international recommendation supporting its cautious adoption. This change aims to enhance survival rates and advance global knowledge on resuscitation strategies.

Subcutaneous implantable cardioverter defibrillator (S-ICD). S-ICD was developed as an alternative to the traditional transvenous implantable cardioverter defibrillator (TV-ICD) to offer easier implantation, a simplified arrhythmia detection algorithm, and prevent placing components in the cardiovascular system. Implanted subcutaneously or intramuscularly, with the generator in the left midaxillary line and the lead tunneled subcutaneously in the left para-sternal region, the S-ICD avoids the complications associated with TV-ICD. However, it is currently unsuitable for patients needing pacing or cardiac resynchronization.

Initial studies focused on younger patients with higher ejection fractions but recent research has shown favorable outcomes even for patients with comorbidities similar to those receiving TV-ICDs.

Developing second- and third-generation devices has reduced inappropriate shocks and addressed previous limitations. Advances like dual-zone programming, automatic QRS-T sensing analysis, the SMART Pass algorithm, MRI compatibility, and atrial fibrillation detection have enhanced S-ICD performance.

Recent studies suggest the potential to expand S-ICD indications to a broader patient population, including those previously overlooked, as the risk of requiring later pacing interventions is low. While cumulative evidence supports S-ICD as a valid and favorable option, particularly for patients with vascular access issues or high infection risk, further research is necessary to solidify existing evidence and evaluate future advancements. This ongoing research will refine the scope of S-ICD and its role in preventing sudden cardiac death, ultimately improving patient outcomes and saving lives.

Outlook
Continuous advancements in defibrillator technology are revolutionizing cardiac care and offering new hope in the fight against sudden cardiac arrest (SCA). From AEDs to the latest S-ICDs, these life-saving devices are becoming more accessible, efficient, and user-friendly. As research progresses and adoption increases, these innovations promise to enhance survival rates and improve patient outcomes, underscoring the critical importance of prompt, effective intervention in cardiac emergencies.

Second Opinion:-

Defibrillators market in India – Trends and future prospects.