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Increasing the impact of care through technology

With the ever-increasing developments in technology, industry will undoubtedly discover new ways to stay safe and healthy. This is extremely useful in the health and safety areas, especially when it comes to heart technology. Heart technology has progressed to incredible new heights, and the industry can only anticipate it to keep growing.

The transition from monophasic to biphasic waveforms was the most significant advancement in defibrillator technology. Biphasic defibrillators, in general, are more effective in terminating arrhythmias at lower energies than monophasic defibrillators. Another accomplishment is the invention of optical defibrillation of the heart, which uses light to restore normal heart activity in a gentle and painless manner to a patient who is experiencing cardiac arrest.

Wireless functionalities are now available on several of the most recent defibrillators. This is used to capture events that occur during codes and to provide reports of the activities done during a code occurrence. Most defibrillators now do automated internal diagnostics once a day to ensure that they are functioning correctly. Some test the battery and send the results to a central computer. Many may be used as a full-fledged patient monitor, with 12-lead ECG, pulse oximetry, and CO2 monitoring included in some models.

Newer versions can send ECG data to a healthcare institution through Wi-Fi or cellular connection before the patient arrives. CPR coaching and/or real-time feedback has improved in certain versions. Newer systems will alert you if there is a problem with a lead or if it is failing to capture pacing data, which is frequently overlooked in an emergency. Aside from ECG, additional characteristics include SPO2 and etCO2.

Furthermore, recent advancements include, but are not limited to, having a more consistent shock with a better level of assurance. The capacity to provide more current is another development. These are critical since it is a life-or-death situation, and these gadgets must be dependable.

One can only fathom where defibrillator technology will go in another generation as technology advances and accelerates. The possibilities are limitless, given the very short lifespan of technology as a whole and the fast developments the world has already experienced.

The Indian defibrillators market in 2020 is estimated at ₹159 crore, and 10,750 units. Biphasic defibrillators, at an 80-percent market share by value, are the mainstay. Accessories to record some parameters as ECG, SpO2, CO2, and NIBP may be added on to the system, as may CPRs, that are accessorized with biphasic models, often for the ambulances, and are retailed in the vicinity of ₹60,000–100,000 per unit.

Monophasic defibrillators are gradually exiting this segment. Only a handful of Indian brands manufacture them, and they find their way into small nursing homes, in smaller cities. They are no longer available in the international market.

The AEDs, already not gaining popularity over the last few years as they can be in a 1.4 billion population size, suffered a major setback in 2020. With government procurement funds diverted to devices used for COVID-19 healthcare, as oxygen concentrators and ventilators, AEDs were way down in the priority list. The first six months of 2020 were a total write-off in case of defibrillators, as they are not directly used in COVID-19 care. With the lockdown announced mid-March 2020, in any case, most public places as cinema halls, restaurants, airports, railway stations shut, there was barely any demand for AEDs.

September onwards, the market started picking up, and in 2021, so far sales are back to the pre-pandemic levels.

Indian defibrillators market
Leading players – 2020
Segment Some leading companies
Monophasic BPL, UNI-EM, and Schiller
Biphasic Premium: Stryker (Physiocontrol), Medtronic, and Zoll;
Mid-end: Philips, Nihon Kohden, Schiller, Comen, and Zoll; Mindray, GE, Stryker, Mediana, Beijing M&B, and BPL
Automatic external Philips, Zoll, Schiller, Beijing M&B, Stryker (Physiocontrol), Cardiac Sciences, Nihon Kohden, Primedic, and Defibtech
ADI Media Research

The global defibrillator market is expected to grow at a CAGR of 5.3 percent from 2021 to 2027 to reach USD 15.5 billion by 2027, predicts UnivDatos Market Insights. Rising adherence to integrated technology, incidences of cardiac disorders, awareness regarding the importance of good cardiac health, and legislative reforms are the key growth drivers for this market.

The International Liaison Committee on Cardiopulmonary Resuscitation (ILCOR) revised the resuscitation recommendations during the pandemic in the aftermath of COVID-19. It recommended offering training to healthcare professionals to improve defibrillation delivery, which might minimize confusion and delay in COVID-19 resuscitation attempts. The training would also protect healthcare workers from additional hazards, and patients suffering from tachyarrhythmic arrests would have the highest possible chance of surviving.

Furthermore, defibrillators were found to be extremely useful in reviving sudden cardiac arrest in COVID-19, which further pushed the demand for defibrillators in the pandemic situation. Timely supportive regulations and increasing adoption are further anticipated to provide this market with a lucrative growth platform in the next few years.

As per the National Heart, Lung, and Blood Institute, more than 250,000 people die every year due to sudden cardiac arrest in the US. All the states within the US have supported and enforced broad public access laws to reduce deaths due to sudden cardiac arrest. According to the American Heart Association, the availability of public defibrillators saves approximately 20,000 lives each year. The state also recommended that public access defibrillators (PADs) be available in public holdings, transportation centers, and residential apartments.

In the UK, a training program for students was introduced, which was conducted by the Advanced Coronary Treatment (ACT) Foundation in association with British Columbia Emergency Health Services (BCEHS) in secondary schools. BCEHS has paramedic volunteers who train teachers to educate students. In certain schools, they are planning to introduce defibrillator training as a part of the physical education curriculum. Such initiatives help in increasing awareness regarding cardiac conditions and the availability of treatment options, such as defibrillators, hence boosting the market growth.

Dr Amit Jindal
Attending Consultant Cardiology,
SGRH, New Delhi
An emergency life threatening medical situation such as a sudden cardiac arrest in public place, where the victim could be far away from a health centre, or have no resources to reach the nearest healthcare facility at the earliest, could be effectively tackled by the people near him. For such an event caused by ventricular fibrillation (VF) or pulse-less ventricular tachycardia, the external defibrillation is the most effective way out. There are two main approaches of a practical AED.

Semiautomatic device. As the name suggests, the defibrillator requires an operator to manually deliver the shock by pushing a button. This type of defibrillator is recommended by current resuscitation guidelines. This makes it the most widely used defibrillator. The rescuer of patient is enabled with capacity to override the device and work independently of visual or audio prompts. Moreover, such a device is safer to operate since there is no risk of electrocution of the rescue personnel. However, there is a drawback of this type of device that it is difficult to be used by untrained or unprofessional respondents. Sometimes it becomes really difficult for them to synchronize with the CPR manoeuvres.

Fully automatic device. In this type of device, the capacity of administering the shock to the patient rests with the device itself, without any external person required to initiate the process. This makes it easier to use even for the laymen. Needless to say, such a device promises better compliance with the resuscitation protocols and can be more effective in delivering desired outcomes. But there is always a risk of electrocution of the rescue person. Thus, it cannot be recommended for extensive use.

Collaborations, partnerships, acquisitions, product approvals, and launches have significantly impacted the market in recent years. Furthermore, there has been a significant increase in the demand for defibrillators due to its increasing awareness, which in turn is fueling the market growth.

The ICD segment dominated the market in terms of revenue share in 2021, and is projected to witness a CAGR of over 7.2 percent from 2021 to 2028. Technological advancements by market players are expected to drive the segment growth.

Product insights. The ICD segment dominated the market and accounted for more than 75 percent share of the global revenue in 2021. The growing demand for ICDs for patients with non-ischemic cardiomyopathy significantly improved the survival rate, and thereby reduced the risk of mortality, which is expected to offer opportunities for the ICD manufacturers, hence fueling the market growth. The ICD segment is further divided into S-ICD and T-ICD. T-ICDs are further segmented into a single chamber, dual-chamber, and CRT-D.

The external defibrillator segment is expected to show lucrative growth over the next six years. The segment is further classified into manual external defibrillators, automated external defibrillators (AEDs), and wearable cardioverter defibrillators. The rapid innovations and advancements in AED technology and the introduction of novel products by key manufacturers to enhance their presence in the market are pushing the development of the external defibrillator market throughout the world. As COVID-19 continues to spread globally, AEDs could mean the difference between life and death for a person with an underlying heart condition. The concerns for those with cardiac issues, who are infected with coronavirus, are very serious.

The COVID-19 pandemic has stimulated changes to many aspects of healthcare, including the response to cardiac arrests both outside of and within hospitals. Focused defibrillation training promises to decrease confusion and delay in COVID-19 resuscitation efforts. For instance, a research study by John A. Stewart published in the Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine in November 2020, stated that focused defibrillation training promises to avoid compromising the care of patients experiencing tachyarrhythmic arrests in the setting of COVID-19. Such a training program might even result in better survival than before the pandemic for this subset of patients.

The semi-automated external defibrillator (SAED) allows the patient to take the decision of sending a shock after verbally requesting it. The SAED contains a shock button. One of the factors contributing to the increase in SAED demand is its usage in countries with high medical tourism, globally, across a range of multi-specialty hospitals.

Globally, cardiovascular diseases are among the top contributors to the disease burden. According to an article published by the National Institute of Health, it was found that atrial fibrillation, the most common arrhythmia in the elderly, affects approximately 0.65 percent of the Japanese population, with its prevalence expected to increase to over one million by 2050. Its presence not only increases the risk of ischemic stroke but also worsens its prognosis. Therefore, it is expected to boost the market’s growth in coming years.

In 2021, the hospital segment dominated the market and accounted for the largest revenue share, with over 89 percent. This is because hospitals are the primary point of care for the treatment of any type of disease, including cardiac arrests. On the other hand, the public-access market segment is estimated to register the fastest CAGR, at around 8.6 percent, with the increasing installation of defibrillators at public places. According to the National Institutes of Health, approximately 18,000 Americans have shockable cardiac arrests in public and outside hospitals with witnesses. It also estimates that 1700 victims are saved annually by bystanders using an automated external defibrillator rather than waiting for emergency medical services. Such factors are expected to drive market growth.

North America dominated the defibrillator market and accounted for a revenue share of 35 percent in 2021. This is because several companies present in the region, especially in the US, are taking up initiatives to improve public access to defibrillators. Europe is anticipated to be the second-largest market for defibrillators owing to the increasing incidence rate of cardiovascular diseases as well as the presence of a huge target population base.

Asia-Pacific is expected to expand at the fastest CAGR over the next six years owing to the presence of rapidly growing economies, such as India and China.

Also, countries, such as Japan have a high penetration of defibrillators, which further boosts the market growth. Companies are also looking to expand their geographical footprint in the region.

Within the Latin American region, Brazil is expected to demonstrate significant growth as the country has a very high population suffering from sudden cardiac arrests. Also, the overall healthcare system of Brazil is improving, which fuels the market growth.

Furthermore, Saudi Arabia and UAE are considered the largest markets for medical devices in the Middle-East, which fuels the market growth in the region.

The market leaders are involved in acquisitions, strategic collaborations, and new product launches to withstand the competition. Major market players are investing in acquisitions and launching new products to enhance their position in the market.

In August 2021, the USFDA granted premarket approval to Kestra Medical Technologies’ Assure wearable cardioverter defibrillator system. The system comprises a wearable device with incorporated sensors, a cardiac rhythm monitor, and a miniaturized AED. It is intended for monitoring and treatment in patients who are at the risk of sudden cardiac death.

In July 2021, Zoll Medical Corporation received clearance from USFDA 510(k) to release the TBI (traumatic brain injury) Dashboard feature on its Propaq M monitor and Propaq MD defibrillator. This feature provides clinical-decision support for managing patients with TBI and was previously available in international markets, but with the FDA clearance it is now available in the US market as well.

Dr Aparna Jaswal
Director, Department of Cardiac Pacing & Electrophysiology,
Fortis Escorts Heart Institute, New Delhi
The global defibrillators market exhibited strong growth during 2015–2020. Looking forward, the market is expected to grow at a CAGR of around 7 percent during 2021–2026. Keeping in mind the uncertainties of COVID-19, the direct as well as the indirect influence of the pandemic on different end-use sectors needs to be monitored. The increasing prevalence of cardiovascular diseases (CVDs) and sudden cardiac arrest (SCA) across the globe is one of the key factors driving the growth of the market. Various technological advancements and the development of wearable cardioverter defibrillators (WCDs) that can aid in predicting the risks of SCAs are creating a positive impact on the market growth. Other factors, including the implementation of favorable policies to promote training and awareness regarding defibrillators, along with extensive research and development (R&D) activities and increasing government investments in the healthcare sector, are projected to drive the market further. Growing focus toward public access defibrillator (PAD) by the public and private organizations has fueled the market growth. Moreover, advanced defibrillator devices, rapidly growing geriatric population with elevated risk of targeted diseases, and increasing incidences of cardiac diseases among all ages are further driving the market growth. However, product failures and recalls, increasing pricing pressure on players, and lack of awareness about sudden cardiac arrest (SCA) are restraining the growth of this market.

In March 2021, the Rankin government made an announcement that all public schools in Nova Scotia would be provided with automated external defibrillators. The government made an investment of USD 700,000. The purpose of this investment is to ensure the availability of these devices in the event of a cardiac emergency.

In January 2020, Medtronic received the CE mark for its Crome and Cobalt portfolio of defibrillators. This significantly enhanced the company’s cardiac solutions offerings and allowed it to commercialize the products in the market.

In April 2020, Philips made an announcement that its emergency care and resuscitation (ECR) business was resuming manufacturing and shipping of external defibrillators for the US. The company was notified that the USFDA had lifted the restrictions imposed on the manufacturing and distribution of defibrillators in the US.

In July 2020, Abbott won FDA approval for its next-generation Gallant ICD and cardiac resynchronization therapy defibrillator (CRT-D) devices, which was equipped with Bluetooth technology and an accompanying smartphone app. This approval places Abbott in an advantageous position over other devices and may allow the company to recover faster from the impact of the COVID-19 pandemic, because it enables physicians to identify abnormal heart rhythms and provide earlier interventions.

Some of the major players operating in the defibrillators market, which are extensively involved in the development of AEDs, include Stryker, Zoll Medical, Philips, and Nihon Kohden. Other players include Schiller, Mindray Bio-Medical, Mediana, Opto Circuits, CU Medical System, Medtronic, Abbott, Boston Scientific, and Physio-Control.

Future cardiovascular disease treatment will involve more remote monitoring. Much of the global market for pacemakers alone – valued atjust under USD 3billion in 2020 – could be overtaken by devices that add remote capabilities.

Future cardiovascular disease treatment will involve more remote monitoring. Much of the global market for pacemakers alone – valued at just under USD 3 billion in 2020 – could be overtaken by devices that add remote capabilities.

Beyond cardiac rhythm management, the potential for remote monitoring in cardiovascular treatment is limitless. There are plenty of market shares up for the taking for devices offering remote monitoring features.

Some companies are making significant strides in this area, with remote-monitoring functions built into some of their cardiac rhythm-monitoring devices, including implantable cardioverter defibrillators (ICDs) and pacemakers. Using the remote functionalities built into these devices, physicians can receive and interpret heart signals from their patients and make treatment decisions remotely.

The ability to diagnose and treat diseases remotely is an attractive option for many reasons. In addition to providing better care for remote communities, which have fewer options for in-person treatment, remote monitoring reduces in-person physician visits overall and reduces strain on the healthcare system.

The idea of remote monitoring to treat diseases has gained even more popularity during the COVID-19 pandemic – a time when healthcare providers are looking for as many ways as possible to reduce strain on healthcare systems.

Historically, remote monitoring in the cardiovascular space has focused on wearable devices to monitor patient metrics, such as heart rate. As the technology has progressed, wearables have become available to track even more complex data, including the heart’s electrical activity.

Exciting defibrillator technology trends to look out for. When bulky, complex hospital defibrillators were converted into portable automated external defibrillators, it was a life-saving breakthrough, allowing people with no medical or first-aid training to save lives. So, where is this technology heading and what buyers can expect from innovations in the future?

Smaller, more compact design and engineering. While current AEDs are not very heavy or bulky, one can see them becoming much smaller units in the future. This will help in several ways, making them more portable (one could slip it into their backpack on a hike, keep it in the reception of small business or store in car first-aid kit, for example), easier to store and easier to place throughout a building.

Easier to use. Current AEDs are designed to be used by anyone, even children, to safely restart a heartbeat, but the user interface and instructions have not changed much over the years. We live in a time where technology has changed every facet of our lives, creating home assistants, smart appliances, apps, and smartphones that are connected and offer innovative user-friendly interfaces and features. It would be exciting to see some of that spill into the world of AEDs, where people can be empowered more effectively to save lives. Imagine an AED that you could ask questions of and get accurate answers as you treat a person that connects to emergency services and GPS automatically, and actively supports your lifesaving efforts. This would make bystanders more confident to act, especially in circumstances involving strangers, small children, or unusual environments.

Improved patient care. For doctors to treat patients as effectively as possible, especially in a time-sensitive situation like SCA, they need patient data. Some new AED technology records patient data from the moment treatment starts – when the AED is attached to the patient – and makes it transmittable to emergency services and hospitals, ensuring the doctors waiting for the patient’s arrival have the most current and most accurate medical data on which to act. This allows doctors, surgical teams, and medical teams to provide more accurate, more insightful patient care, something that can directly impact on patient outcomes, survival rates, and long-term care requirements.

Reduced maintenance. One of the most significant challenges when it comes to public access and private AEDs is maintenance. Without regular maintenance, which includes running testing procedures, updating software and replacing key components like electrode pads and batteries (which have a finite lifespan), an AED is unreliable at best during a cardiac emergency. It is up to the staff and the AED owners to keep their unit in good working order.

One of the new technologies on the horizon that may challenge this issue is a single-use, multi-shock AED. Buyers will not have to worry about time-consuming maintenance because they only use the unit once, then they will send it to be recycled. This option was highly cost-prohibitive in the past, but MedTech innovators are seeing promising results for affordable single-use AEDs that run self-checks and are simple to maintain. Every advancement that makes it easier to have an on-site AED makes it just a little bit easier to save lives.

New magnetic threat to ICDs – what does this mean for the industry? Magnetic interference with pacemakers and ICDs has been well-documented for several years now. Patients are advised not to linger too long near security alarms in shops or wear clothing with magnetic fasteners over the chest, should this cause interference with the devices inside them. While these circumstances are fairly easy to avoid, modern technology has brought in a new magnetic threat to ICDs users – Qi charging.

Wireless Qi charging works by transferring energy from a charger into a receiver in the back of a device, such as a mobile phone or smartwatch, via electromagnetic induction. An induction coil inside the charger creates an alternating electromagnetic field, which a receiver coil in the device converts into electricity to charge its battery.

Apple has now released a list of its products that could potentially interfere with a pacemaker or ICD – including the iPhone 12, Apple watch, and Mac laptops – and the USFDA has issued a public health warning about the risk of magnets in consumer products to pacemaker and defibrillator users. While this risk is still considered small, it is not non-existent.

What does this mean for the industry?
As wireless Qi charging becomes increasingly popular, it is hard to say what impact this could have on implanted cardiac devices. It may well mean that in the future, they will need to be designed differently and the magnetic element will have to be reworked.

Henry Ford Heart & Vascular Institute cardiologist Dr Gurjit Singh says, “I am not aware of any third-party company that can do anything. I think it is something that has to be done by the device company itself. Their engineering has to change. Maybe the switch will have to be something totally different, not even magnetic, or only be activated by bringing the magnet to the chest in a specific fashion to make it tougher for the device to react. Maybe we should raise the magnetic threshold, so the magnet has to be stronger to be switched on and off.”

However, even if future pacemakers and ICDs implement a novel design that removes the risk of magnetic interference from everyday technology, there will still be millions of people around the world fitted with devices that can still be affected.

It is worth remembering that the risk to the health of pacemaker and ICD users from magnetic smart devices is still considered very minor. So far, there are no known fatalities that have resulted from an iPhone interacting with an implanted cardiac device – but it is not impossible, and the risk increases as more and more devices are fitted with large, powerful magnets.

Singh says, “Let’s assume you have a high-risk patient with a defibrillator and he is lying back with the phone in his shirt pocket and goes into a deadly rhythm and needs the defibrillator to shock him, but his iPhone is sitting there, stopping that from happening. It is a lot of ifs before that point, but we have seven billion people on the face of the planet so the chance of that happening is definitely there.”

Since its debut implantation in humans in 1980, defibrillators have made great strides, solidifying their significance in preventing SCD. They are indispensable today in successfully managing fatal ventricular arrhythmias. Defibrillators continue to evolve despite four decades of iterative development advancements and updates, and current research is underway to enhance the ever-expanding indications for their usage.

With more advanced technology, the potential integration with leadless pacing, and the possibility to serve as a remote monitoring device to recognize atrial fibrillation, acute ischemia, or electrolyte imbalance, the application of defibrillators is rapidly evolving. These devices are expected to become more cost-effective and safer in coming years.

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