Indian Institute of Technology Kanpur (IIT-K) has created the country’s initial ‘man-made heart’ known as the left ventricular assist device (LVAD), which is scheduled for animal testing in March 2025. Dr Amitabha Bandyopadhyay, who leads the Department of Biological Sciences and Bioengineering at IIT-K, described the trials as a crucial step in developing a cost-effective, indigenous remedy for advanced heart failure, setting the stage for human trials.
Dr. Bandyopadhyay discussed the process of developing a more affordable Indian LVAD compared to models costing approximately Rs 1 crore worldwide. Following a successful completion of a set of lab tests, India’s domestically produced LVAD, known as ‘Hridaya Yantra’, is now ready for animal trials, set to commence in March 2025. Dr Bandyopadhyay, chairman of R&D task force of School of Medical Research and Technology (SMRT), stated that the trials will begin with sheep to confirm the device’s effectiveness before progressing to human use.
An LVAD is a device that assists individuals with serious heart failure by aiding the heart’s ability to circulate blood. It specifically assists the heart’s primary pumping chamber, the left ventricle, by assuming its role when it is unable to pump blood efficiently.
LVADs are commonly employed in individuals with advanced heart failure either as a temporary measure until a heart transplant is possible or as a permanent option for those who are not suitable candidates for a transplant. The implantable device extracts blood from the left ventricle and transports it to the aorta to provide the body with oxygen-rich blood.
LVADs are not a substitute for the heart, but they support its operation, providing a life-saving alternative when drugs are not enough. Dr. Bandyopadhyay explained that LVADs are costly and typically imported, which puts them beyond the financial means of numerous patients in India.
The starting point was in March 2022 when Dr. Bandyopadhyay was introducing the institution’s research and development goals to the advisory committee. At the meeting, Dr Devi Shetty, a well-known cardiac surgeon and the founder and chairman of Narayana Health, presented a challenge. He proposed that if IIT-Kanpur could achieve rapid, high-quality product development, why not work on developing an LVAD, a device that is currently unaffordable for many Indians due to its high cost. Currently, LVADs are brought in from the United States and are priced at approximately Rs 1 crore, rendering them unattainable for numerous Indian patients. Dr. Bandyopadhyay remembered that approximately 5000 patients with end-stage heart failure need LVAD every year on average. Dr Shetty’s suggestion led to the swift initiation of ‘Hridya Yantra’ by IIT Kanpur, a program focused on developing a sophisticated artificial heart through challenges.
Although the challenge was agreed to, it was intimidating due to the precision engineering needed to create an LVAD, an advanced mechanical pump meant to work inside the human body. The device needs to imitate the heart’s natural function and work perfectly in the intricate human body environment. Top-notch mechanical engineering was necessary for the success of this project.
Understanding the difficulty of the endeavor, IIT Kanpur initiated a countrywide campaign to hire leading professionals in areas like healthcare research, technology, and innovation. Dr. Bandyopadhyay stated that a broad range of experts from different fields came together to collaborate on developing a cost-effective, locally made LVAD.
Typically, pumps produce noise, generate heat, and are susceptible to malfunctions. Nevertheless, the pump needed to operate within the human body needs to be quiet to not disrupt the patient, generate no warmth to protect against tissue injury, and must be extremely dependable, working without any issues for 10-15 years. “He stated that this was the initial obstacle.”
Nonetheless, he mentioned that the team drew inspiration from a Maglev train in Japan, which uses electromagnets to lift the train above the track instead of wheels. This technology eliminates friction, enabling the trains to reach higher speeds and operate quietly and smoothly.
The next task was to guarantee the pump’s efficiency while operating in the human body. Dr Bandyopadhyay stated that this pump, in contrast to standard pumps, must pump human blood, requiring the prevention of blood cell damage and the avoidance of blood clot formation.
A high-quality design with precise engineering was necessary for this. At first, computer models were used for the process, but after extensive research and development over many hours, days, weeks, and months, the team successfully created a revolutionary pump. This pump is the first Maglev pump and LVAD in the country, and is now prepared for animal trials.
Another important obstacle was providing power to the LVAD pump located inside the human body. He mentioned that the pump would run on battery and would be linked to an external battery pack using a cord. He mentioned that it is best for the battery to be integrated into the device, however, problems may occur if it needs to be replaced or runs out of power.
Currently, the external battery pouch is considered the most dependable option. Despite being less convenient, this approach guarantees the pump can receive a steady power supply, preventing potential issues such as internal battery failure or disconnection of the wire hanging from the body. LVADs that are imported function in a similar way, necessitating the patient to have the pouch with them constantly.
Dr Bandyopadhyay proudly highlighted the Indian LVAD as a genuine ‘Make in India’ innovation, emphasizing its efficiency and affordability. The professor did not reveal the specific price but guaranteed that if the device passes all tests and is released to the market, it will be within reach for the average person. At present, the LVAD is priced at approximately Rs 1 crore in the international market. He mentioned that the Indian edition is anticipated to be nearly four to five times more affordable.
Over 26 million people worldwide are affected by congestive heart failure on average, with India alone losing more than 50,000 lives annually, while only 10-15 heart transplants are conducted in the country each year. Following the initial animal experiments, the LVAD will be subjected to a series of regulatory animal tests and other assessments prior to being suitable for human implantation. Despite the long road ahead, the finding of this native LVAD has already brought hope to many end-stage heart disease patients who cannot currently purchase expensive imported devices.