City hospital Frontier Lifeline’s medical science park, Frontier Mediville, is all set to manufacture mechanical artificial hearts in association with a firm in Russia.
“We have signed a Memorandum of Understanding with a Russian manufacturer who makes the device, Sputnik, to manufacture artificial hearts. These hearts, also known as left ventricular assistive devices, are generally used in cases of heart failure, where patients are awaiting a transplant.
They help pump blood from the heart to the rest of the body. The latest such device, the ‘HeartMate 3’, manufactured in the United States costs around Rs. 90 lakh. We are hoping to manufacture such a device within Rs. 30 lakh, making it affordable for people in India,” said K. M. Cherian, chairman, Frontier Lifeline, at a press meet on Wednesday.
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At present, Dr. Cherian said, the Committee for the Purpose of Control and Supervision of Experiments on Animals had given their facility permission to conduct trials, so that manufacture of the devices can begin.
The artificial heart will be an implantable device which means the patient can leave the hospital while awaiting a transplant, or, in some cases, may not need a transplant at all if the heart recovers, Dr. Cherian said. The hospital will also soon begin phase III of its clinical trial to evaluate the safety and efficacy of xenograft valves for the heart -- valves sourced from animals.
About 35,000 heart valve replacements are performed annually in the country, said Dr. Cherian. Most of these, he said, use imported mechanical valves, with prices ranging from Rs. 50,000.
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TTK Chitra, an indigenous mechanical heart valve, which is cheaper, is used too, but mechanical valves, Dr. Cherian said, require life-long anti-coagulation, necessitating frequent blood testing.
The hospital’s heart valve trial involves biological and bioprosthetic valves which do not require anti-coagulation and do not have sudden failures like mechanical valves, making them more desirable, he said. The biological prostheses are of three kinds: the porcine pulmonary artery, the bovine jugular vein and the bovine pericardium, said Dr. Cherian. These valves are harvested from abattoirs in Hyderabad and Kerala, with sterile precautions and have now been used in 600 patients in phase II of the hospital’s clinical trials, he said. “Over 90 per cent of them are alive and doing well,” he said.
Multi-centric
Phase III of the trial will be multi-centric, with the valves supplied by the hospital used in surgeries at AIIMS, New Delhi, and PGI, Chandigarh, involving a total of 50 trial subjects. If all goes well, the hospital will begin commercial manufacture of these valves and they will cost around Rs. 25,000, said Dr. Cherian. The hospital is also in collaboration with Georgia Institute of Technology, US, to develop an indigenous bioprosthetic heart valve. Scientists from the Institute will train Mediville staff to manufacture this.
The devices are used in cases of heart failure, where patients are awaiting a transplant