Obesity Phenotypes, Diabetes, and Cardiovascular Diseases

Abbott Falls Behind In Stents Race

While Abbott Laboratories awaits word from the Food and Drug Administration on when or whether the agency will review its experimental drug-coated stent, a rival has jumped ahead in what could be a critical review process for the troubled market for devices that unclog heart arteries. Because the only two drug-coated stents on the U.S. […]

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Originally Published: September 1, 2007 at 1:00 AM CDT

Abbott Wins Approval For Advanced Coronary Stent

US MEDICAL device giant Abbott has secured approval for a breakthrough coronary stent, developed in part at the firm's Clonmel plant.

The Food and Drug Administration (FDA) approved the Xience V drug eluting stent for sale in the US market late on Wednesday night.

The Tipperary facility was instrumental in developing the manufacturing process for the new product. It is one of only two Abbott plants worldwide that will produce the drug-eluting stents.

Abbott has been selling the stent outside the US for the past two years but the country is seen as the key market for coronary care products, accounting for 65 per cent of the stent market.

"Abbott's Clonmel facility has been instrumental in bringing this exciting medical device to the worldwide market," said Damian Halloran, divisional vice-president, Abbott Vascular Operations in Ireland.

Mr Halloran is confident Abbott can quickly secure a 40 per cent share of a market that was worth $4 billion worldwide before a scare last year over complications with drug eluting stents.

"The real exciting thing about the Xience V is that the safety and efficacy . . . Is 45 per cent better than [rival Boston Scientific's] Taxus in terms of major adverse cardiac events, so it has truly resolved that fear in the marketplace around whether drug eluting stents are better than bare metal stents.

Stents are tiny wire mesh tubes used to prop open arteries that have been cleared of blockages in angioplasty procedures. Drug-coated versions are designed to help prevent vessels from reclogging as a result of scar tissue.

Until now, just three companies had approval to sell stents in the US market.

Johnson Johnson were the first to market in 2003 with its Cypher stent but that was quickly overtaken by the Taxus stent developed in Ireland by Boston Scientific. Earlier this year, Medtronic won approval to market its Endeavour stent in the US.

While the market has contracted in the past year, a series of recent studies pointing to the efficacy of drug eluting stents in general, and the Xience V in particular, has raised expectations in the industry.

The Clonmel plant produces the majority of the bare metal stents used by Abbott. These are then coated with a drug licensed from Novartis at both the Clonmel plant and at Temecula in California.

FDA spokeswoman Karen Riley said the agency is requiring Abbott to continue monitoring the product along the same lines prescribed for Medtronic upon Endeavour's approval.

Abbott secured the research behind the Xience stent as a by-product of Boston Scientific's takeover of Guidant in 2006. Because of Boston's then dominant position in stent sales, it was obliged to sell on the Guidant vascular division. Abbott was the buyer.

Boston Scientific has also been licensed by the FDA late on Wednesday to sell Xience V under the Promus brand name.

Abbott's Stents In India - Price Caps Mean Products Disappear From The Market

Politicians really do need to understand that these supply and demand things do in fact work. Economists have not been howling at the Moon all these years, it really is just true that price fixing does not work. And so it is with the Indian government's insistence on capping the price of heart stents. Those stents which were more expensive before the price cap will no longer be available:

Healthcare major Abbott has decided to withdraw two types of stents from the Indian market in the wake of drug price regulator National Pharmaceutical Pricing Authority's (NPPA's) move to cap the prices.

This is not a surprise and thus should engender no surprise in anyone:

Healthcare major Abbott on Friday announced the withdrawal of two of its latest generation coronary stents from India, including a bio-absorbable stent it had introduced four years ago, citing commercial unviability.

It costs what it costs to produce to produce something. As and when a price cap is lower than that price then the product disappears from the market. There are no exceptions to this rule.

Two months after the Indian government capped prices of coronary stents at Rs 29,600, US manufacturer Abbott has filed an application with National Pharmaceutical Pricing Authority (NPPA) to withdraw two of its premium stents from the Indian market, stating "commercial unsustainability".It is learnt that the company sought to withdraw its revolutionary dissolvable stent, Absorb, priced at Rs 1.9 lakh each before the cap. The other, Xience Alpine, introduced in 2016, was priced at Rs 1.5 lakh till February 14, when NPPA slashed stent prices.

Lakh is 100,000 for those not blessed with an understanding of the South Asian numbering system. So, the government decides that it would be nice if stents were good and cheap for patients. Something which is undoubtedly true. They the fix the price for stents nice and low and the expensive stents disappear from the market. This is also going to be true. For supply and demand, those nice little charts so beloved by economists, are real things, they are a true description of this universe.

When governments have rent control to make housing nice and cheap then people stop building it. When governments, like that in Venezuela, fix the price of food nice and low then people stop growing it. Similarly, when governments fix wages nice and high with a minimum wage then people stop buying so much labour. Shrug, this is just the way human beings work. A lesson that we really want to understand before the US government decides to make health care and drugs nice and cheap by fixing the price of it.

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