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Drug and medical-devices maker Abbott has brought into the country its drug-eluting absorbable stent, said to be the first of its kind, globally. The bioresorbable vascular scaffold (BVS), as the device is called, is used in the treatment of coronary artery disease (CAD).
It is used to remove blocks in a blood vessel but, unlike a metallic stent, here the device dissolves into the body in about two-three years, Amit Kumar, Abbott’s Regional Director for South and South-East Asia told Business Line .
Natural material
The blood flow to the heart is restored and the dissolvable device leaves behind a treated vessel that may resume more natural function and movement because it is free of a permanent metallic stent, he explains. A stent is a thin wire mesh used to remove blocks in blood vessels.
The advanced versions are drug-coated or drug-eluting stents (DES). After the catheter was used in the 1970s to remove blocks in the artery, bare-metal stents and DES – the bioreabsorbable scaffold is the “fourth revolution”, says Kumar.
The absorbable device is made of polylactide, a naturally dissolvable material used in medical implants such as dissolving sutures, he said. The device has been distributed to about 30 cities across India, he said, without divulging the price of the product. Doctors and representatives familiar with the development estimate the product would cost the patient between Rs 2-3 lakh, per stent. A DES costs between Rs 70,000 and Rs 1 lakh-plus.
While comparable to a good DES, Kumar says, the scaffold’s benefits are that it dissolves. So the repaired blood vessel can expand and contract as needed to increase the flow of blood to the heart in response to normal activities such as exercising; and the need for long-term treatment with anti-clotting medications may be reduced, he explains. Future interventions and investigative procedures like scans etc would be unobstructed as there is no permanent implant, he adds.
But stressing the importance of preventive measures, Dr Aashish Contractor, Head of Preventive Cardiology and Rehabilitation at the Asian Heart Institute observes, whether the dissolvable product is a game-changer will be seen only after it gets used for a period of time. Different stents, when they were launched, were touted to be revolutionary, he points out.
Surveillance
The product was launched in India after clinical trials on 100 patients, besides post-marketing surveillance will be continued on the product, Kumar said. Imported from Abbott’s base in California, the facility was ramped up to supply India, he added.
The India launch follows within months after launch in Europe in October. However, the product is yet to be launched in the United States that has a stringent regulatory process. India is among the first large countries in the Asian region as well to get the product, the official said.
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