Hyderabad: Absorbable stents i.e. Absorb Bioresorable Vascular Scaffold and Absorb GTI Bioresorbable Vascular Scaffold were recalled from the market in India after a review by cardiologists in Europe and US found that they increased the risk of stent thrombosis and severe blood clotting in the area close to it.
The decision, taken in April, came as a major jolt to the heart care industry. Stents rule the heart care market; so when the latest generation of stents turned out not up to the mark, the industry was left wondering what went wrong.
In India, 10,000 absorb stent implants were carried out, and patients were being closely followed up. Bio-absorbable stents are the latest in stent technology, but cardiologists realise that the previous generation drug-eluting stents continue to be good for patient care and they would want to stick to those for now.
Absorb stents were launched in September 2012 and were claimed to be very effective in the treatment for coronary diseases. Clinical trials were carried out on 100 patients in the country before introducing them into the market.
Data from the Cardiology Society of India shows that 10,000 bio-absorbable stents have been used in the last five years. The stents cost over '2 lakh a piece.
The procedure of implanting this stent is a bit more complicated than normal metallic stents. It requires specialised imaging like Optical Coherence Tomography (OCT), and its navigation into the body is a time-consuming and strenuous affair for the team of heart specialists. Absorb stents were not used for all patients. Their use requires specific reasons — like very hard blood clots, too many in one row etc.
India accounts for third of the $132 million global revenue in stent, according to a 2014 market report.
