It is being billed as a breakthrough innovation for patients with clogged arteries. On Wednesday, December 19, global pharma company Abbott launched its "Bioresorbable Vascular Scaffold" in India. The product is a kind of stent or tube that is used to clear blockages and has been cleared by the Drugs Controller General of India (DCGI).
Announcing the launch, Abbott described the product as the "world's first drug eluting (drug coated) Bioresorbable Vascular Scaffold" and said it had the "potential to revolutionise treatment of coronary artery disease". It will be made available to hospitals from December 20. The company has launched the product in several countries, including in Europe, since October. However, it is yet to get approval from the US Food and Drug Administration.
Arteries or blood vessels get clogged because of the build-up of cholesterol in the body. However, blood vessels are also elastic and can be expanded. Earlier, this was done by inserting simple stents. Then came drug-coated stents that reduced chances of blood clotting. The Bioresorbable Vascular Scaffold is being touted as the latest advance in this field. It is made up of material that goes into the sutures used in operations. And so, these pipes dissolve in a about a year's time after creating a new passage for blood flow.
Speaking to BT, Amit Kumar, Abbott's Regional Director and GM for South and South East Asia, claimed the device was the first of its kind.
However, at Rs 3 lakh per piece compared to around Rs 1.2 lakh for a normal high-quality stent, it will be quite expensive for the average Indian. Dr Samuel Mathew Kalarickal, a leading cardiologist practising at Lilavati Hospital in Mumbai and Apollo Hospitals in Chennai, feels that less than two per cent of the country's population will be able to afford it.
Kalarickal, who was the principal investigator in trials for the device in India, says it is a welcome innovation. "We found that this stent has all the advantages of a normal stent with an added long-term benefit in its getting absorbed in the body in about 12 months," he says. Ten of his patients have opted to have the stent implanted over the next few days.
Dr Devi Prasad Shetty, founder of Narayana Hrudayalaya, welcomed the launch cautiously. "It is a new innovation and we must welcome it. But we still need to see the long-term results and the stent's patency (ability to remain unobstructed) over the long term."
When BT raised these concerns with Abbott's Kumar, he said: "For the first 30 patients (on whom this device was used), there is more than five years of data available and there are no reports to date of any cardiac-related deaths or of blood clots."
Cardiac disease is huge and a growing problem in India. "It is a vastly under-served market," says Kumar, adding that around 50 million people are estimated to have been diagnosed with coronary heart disease in the country.
If stents of this kind become more affordable, they will be a boon to many of these patients.