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.
