Biphasic Defibrillators – Next Wave Of Opportunities

With most government tenders looking for advanced features and biphasic defibrillators being in huge demand, the Indian market surely looks positive.

Defibrillators and the treatment of SCA have come a long way in recent years! From great big bulky devices that were on trolleys in hospitals and only used by authorized doctors, to now being located in many public places wherever people are likely to be. For the last couple of years, technology of defibrillators has been gradually changing from monophasic to biphasic, which is more effective. Also, a major change has been observed with the demand of higher parameters in the biphasic defibrillator, which include SPO2, NIBP, and ETCO2. This also makes it a multi-parameter defibrillator. The market has been seeing an increase in demand of these parameters from the government sector lately.

Looking toward the trend of last three years, it seems that the defibrillator market in India will see a considerable amount of growth year-on-year. With most government tenders coming up with the requirement for advanced features and biphasic defibrillators being in huge demand, the market surely looks positive.

Indian market dynamics
The Indian defibrillator market in 2017 was Rs 133 crore, estimated as 9430 units. Biphasic defibrillators, the highest priced in this segment dominate the market with a 66 percent market share by value and 46 percent market share by volume. Large hospitals have biphasic defibrillators on every floor. The government was not a major buyer in 2017. 2018 looks promising as the government has indicated its plans to procure fully loaded biphasic defibrillators.

The AED defibrillator market grew by 20 percent in 2017 over 2016. With increasing awareness, they are being installed in public places like airports, malls, hotel lobbies, schools, and reception areas of large corporate offices all over the country. However, one of the factors restraining demand is their disposable nature as electrode pads cost Rs. 2000 and have to be changed with every usage.

India is one of the few countries in the world where monophasic defibrillators continue to be popular, albeit only in the rural and semi-urban areas. With stringent budgets, these medical practitioners also do not seem to fully appreciate the benefits of the biphasic defibrillators. The defibrillator is a mere compliance formality. BPL is the sole supplier of this product. Biphasic vendors see this as some major replacement market once medical facilities in rural decide to upgrade.

Technological advances
Twenty years ago is approximately when the first dual-chamber defibrillators were available for use. Up to that point, defibrillators had undergone some advances, including anti-tachycardia pacing, biphasic shock waveforms, and using the implantable cardioverter defibrillator as an electrode, but only provided ventricular backup pacing from a single ventricular lead. These were not very good at preventing the heart from going too slow, so sometimes there was a need to insert a separate pacemaker and defibrillator in the same patient. Since that time, there have been huge developments. For instance, combining a dual-chamber pacemaker with an ICD, which is crucial in some patients, is a big advance over the single-chamber pacemaker/ICD combination.

Transvenous pacemakers and ICDs are effective treatment modalities for cardiac bradyarrhythmias and tachyarrhythmias. However, these systems are associated with device-related complications, mostly related to the transvenous leads, which result in morbidity and mortality. Transvenous pace and shock leads have shown high failure rates during long-term clinical follow-up. Device infections (sometimes involving the pocket but more so when systemic) are associated with a high risk of mortality.

To reduce complications related to transvenous leads, both the leadless pacemaker and the subcutaneous implantable cardioverter-defibrillators (S-ICDs) were introduced and have shown clinical efficacy and safety. To date, these systems are only available for patients either requiring single-chamber right ventricular pacing or shock-only defibrillation therapy. Combined use of both devices could bring the benefits of leadless therapy to a larger patient population by providing both bradycardia pacing and defibrillation therapy.

A wearable cardiac defibrillator (WCD) is an external vest-like device that is intended to perform the same functions as an ICD without requiring an invasive procedure. This device is used to monitor and treat abnormal heart rhythms in people at risk. The vest includes an electrode belt that contains the cardiac monitoring electrodes and the therapy electrodes that deliver an electrical shock if a life-threatening ventricular arrhythmia is detected. The WCD is programmable and communicates with the patient through voice and display messages, tones, or alarms and vibration against the skin.

In the past, individuals with ICDs were limited in terms of full body magnetic resonance imaging (MRI) and were often prevented from undergoing chest scans. Fortunately, recent advancements have allowed for the creation of MRI-compatible ICDs and patients with the new MRI-compatible ICDs can undergo this important diagnostic imaging without fear of complications. Leading manufacturers have released devices that allow individuals to undergo full body scans, even after implantation.

Another major change over time is in the way physicians follow their patients. They can perform remote monitoring of patients to augment in-person checks. Remote monitoring also affords the chance to adjust clinical care after detecting a change in the patient’s clinical condition or device malfunction, which may improve major clinical outcomes such as death and hospitalization. The device telemetry could only travel a few inches, but now it transmits several yards. Most recently, the devices use Bluetooth for telemetry. The ICD uplinks to the bedside monitor, which uses cellular technology to link to central databases and uses the Internet to send the information to the physicians. The patient does not have to do anything but sleep. This has revolutionized the way physicians follow the devices and the patients.

Most of the recent defibrillators can also do automatic internal diagnostics usually once a day to ensure the defibrillator is working properly. They also test the battery and report the status back to a central computer. Some of the modern models also include improved CPR coaching and/or real-time feedback. CPR feedback is a new advancement that most manufacturers are adopting and SpCO (carbon monoxide) measurement for pre-hospital models is also becoming popular.

Way ahead
With the never-ending advancements in technology, there is no doubt that we will find better ways to stay safe and remain healthy. Science is an evolving practice that changes as technology improves. This is especially beneficial in the health and safety fields, where heart technology is concerned. The AED for example, once did not exist. It was not until technology improved, and researchers realized that electrical shocks could be administered to the heart to save a life, that these lifesaving machines came into being! Heart technology has advanced to impressive and astonishing heights, and the industry can only expect it to continue to expand.