The everolimus-eluting coronary stent, which won CE Mark approval in the European Union this week, is designed to allow cardiologists to treat the complex lesions that make up roughly 70% of cases. It offers a thinner profile, increased flexibility, longer lengths and smaller diameters than previous stents.
Earlier this year, India capped the price of coronary stents, cutting prices by as much as 75% for metal, drug-eluting and bioresorbable stents and setting limits on trade margins, discounts and other promotions used on higher-end products.
In light of the caps Abbott isn’t planning to bring Xience Sierra to India, according to LiveMint.
“While we are aligned with the government’s intent for broader access to healthcare, we’re disappointed that differences among stent generations are not recognized, which could restrict future investment and innovation that benefits patients. In the current environment, Abbott is not planning to launch Xience Sierra in India,” a spokeswoman told the news site.
“India would be isolated and devoid of newer technologies because of stringent policies. It is a high-end stent, probably the best so far, with thin struts, excellent trackability thus able to treat complex lesions,” added Dr. Nishith Chandra of the Fortis Escorts Heart Institute.
“If the companies have to sell in India they have to respect Indian laws and regulations, same as we do when we sell to EU/USA and other countries. The National Pharmaceuticals Pricing Authority and Indian Medical Association have stated that differential pricing is possible for innovative stents on proven clinical superiority performance. Abbott has just launched a new variant in EU. Let them prove its patient safety and credibility. Possibly with proven clinical superiority data they may have a justifiable case to seek a higher reasonable MRP in future,” said Rajiv Nath of the Assn. of Indian Medical Device Industry.