India’s long-drawn efforts to bring drugs and medical devices under price control has led US-based Abbott Laboratories to withhold its new coronary stents, described by one Indian surgeon as the best so far, from the Indian market.
The high-end stents, called XIENCE Sierra and marketed in the Europe, make it easier for surgeons to access and unblock difficult-to-reach lesions in the heart—with new features such as thinner profile, increased flexibility, longer lengths, and small-diameters.
But Abbott said it is not planning to launch the stent in India in the “current environment".
Citing disappointment over government’s move to cap prices of stents, an Abbott spokesperson said, “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 coronary stent is a wire mesh tube used to clear blockages in coronary arteries and prevent heart attacks.
On Tuesday, Abbott received CE Mark for XIENCE Sierra, which allows a company to sell the device in the European Union (EU) and other countries that recognize CE Mark.
According to the Abbott spokesperson, more than eight million people worldwide have received a XIENCE stent since its initial regulatory approval.
Abbott has also applied to the US Food and Drug Administration (FDA) for XIENCE Sierra approval.
Abbott says the new stents include features that make it easier for cardiologists to successfully complete complex procedures that now account for up to 70% of cases. “XIENCE Sierra can help cardiologists be even more precise when implanting the stent, which is important for efficacy and safety," said Charles Simonton, managing director (MD), chief medical officer of Abbott’s vascular business.
“Its design, range of sizes, and increased flexibility mean doctors don’t have to use as much force when they implant a XIENCE Sierra stent compared to other stents."
Dr Nishith Chandra, director, Interventional Cardiology, Fortis Escorts Heart Institute, said that “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".
However, Rajiv Nath of the Association of Indian Medical Device Industry (AiMeD), applauded the efforts of the government in making essential medical devices affordable.
“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 (NPPA) and Indian Medical Association (IMA) 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," he said.
The NPPA had in February cut the average price for stents by as much as 80% and set ceilings for all drug-eluting stents and bio-resorbable vascular scaffolds.
The government used an emergency clause in February to direct companies to maintain supplies for six months, but the expiry of the order in August saw many stent makers—such as Abbott and Boston Scientificºseeking withdrawal citing commercial unviability.
Abbott Healthcare Pvt. Ltd received permission to withdraw its premium stent Xience Alpine and its dissolving stents.