Are surgical stents manufactured in India as good as those made abroad? Contradicting statements made by several manufacturers in the past, it has been proven that Indian-made stents are of high quality. According to a recent study revealed by German cardiologists, Indian-made stents are just as up to the mark as the best out there, making it much more affordable for those who may need a stent.
ISAR-TEST 4 is the name of the clinical trial taken up to determine where the quality of Indian stents stood in comparison with those which are made internationally. The decade long study which was undertaken, proved that the biodegradable-polymer based stent which was produced in India was a “worthy match” to the American-made Xience brand stent.
Stents are commonly made out of metal or a plastic-like material and are used to create a passageway for blood flow when a blood vessel becomes clogged. Drug eluting stents, DES, are coated with certain medications which are released slowly, overtime and help to prevent growth of scar tissue in the lining of the blood vessel. This helps ensure that the artery remains smooth and that blood flow is continuous.
“This is definitely a good thing, going forward this will make such surgeries more accessible and affordable to those who may need the same,” says Dr Prateek Bhatnagar, a Hyderabad-based cardiothoracic surgeon, “It will now pave the way to ensure that those who require stents will be able to access them at a lower price.”
Price Capping of stents
Controversy surrounding stents have been around for some time. In fact, in 2017, several manufacturers of medical devices came together to argue that capping prices on medical stents would lead to production of a low quality product. This was in response to government’s move to cap the costs of DES at the time.
Contradicting their arguments, however, the results of the ISAR-TEST 4, show that a product made at a relatively lower price can still be of high quality.
Translumina Therapeutics LLP, is the first Indian manufacturer which has data to show that it’s product is equivalent to a foreign counterpart. All this in an industry heavily dominated by American companies. The 10-year long study monitoring the safety and efficacy of the stents made by the company in patients, shows that the drug eluting stent (DES) produced by the company matches the quality of the ones provided by other companies, traditionally preferred for heart surgeries.