There are thousands of Irish jobs in the growing and lucrative medical devices business, writes Dominic Coyle.

PAULINE MCCARTHY knows all about stents and not just because she works on the production line at Abbott's plant in Clonmel, which is one of the largest producers of the tiny metal mesh devices.

When Pauline's husband Anthony needed treatment for coronary disease recently, it was one of Abbott's new Xience V drug-coated stents that doctors placed inside his coronary artery to keep it open and allow blood to flow to his heart.

Abbott this week won approval from the US Food and Drug Administration (FDA) to sell the Xience V stent in the US market, which accounts for around 65 per cent of stent sales. With two years' experience behind it selling outside the US and a sizeable sales force in the US, the firm is hoping to grab up to 40 per cent of the global market for drug-eluting stents.

The decision is another boost for the medical devices sector in Ireland, particularly the stent business. While much of the RD behind the Xience V stent took place in the US, the Clonmel plant was pivotal in designing the process that allows the tiny metal devices to be produced on an industrial scale. It is also one of just two facilities that will produce the stent for the global market.

Ironically, if it meets analysts' expectation by becoming the market leader, Abbott's Xience V will topple another Irish-designed product - the Taxus drug-eluting stent produced by Boston Scientific. Much of the development of Taxus took place in the US company's Galway plant, which remains one of just two facilities worldwide producing the Taxus.

Ireland's success in attracting such business is down to a number of factors.

"We are making something that goes inside a human body, so regulatory compliance and a history of regulatory compliance and a good FDA record are critical," says Damian Halloran, divisional vice-president of Abbott vascular operations in Ireland.

Labour supply is also key. "Ireland has done a nice job in biomedical engineering and in a lot of the courses they have put around the hub areas like Galway and Limerick to build tech skillsets," says Halloran.

However, we are also losing competitiveness, and justifying investment in labour-intensive manufacturing is increasingly difficult.

"High-margin, high-tech products are still viable in Ireland because of our technical competencies and our tax regime," Halloran says. "The tax regime is the reason why a lot of companies are in Ireland . . . Ireland is still competitive, but you would not want to take it for granted."

All four of the main players in the coronary stent market have operations in Ireland, with Johnson Johnson Cordis currently building a new facility in Cashel, Co Tipperary. Between them, they employ thousands of people, largely outside Dublin. For IDA Ireland business development manager Enda Meehan, the most encouraging thing is that companies like Boston Scientific, Abbott, Johnson Johnson Cordis and Medtronic are not using Ireland simply as manufacturing bases, but also for development work on next-generation products.

Apart from employment opportunities and contribution to the economy, Meehan says the presence of major players in the stent sector has triggered a series of downstream opportunities in areas like catheter and guidewire development, and manufacture for both international and indigenous players.

For now, Boston Scientific may be choosing to sell the Abbott Xience V stent under licence as Promus in a move that will probably cost its own Taxus further market share, but spokesman Paul Donovan says the company has no intention of giving up its market leadership.

"We are currently working on the next generation Taxus Liberté stent for which we expect to receive FDA approval mid-year, and we also have the Element stent in development, which will offer two different drug coatings," including the Novartis-owned drug everolimus, which is used on Abbott's Xience V.

"Our intention is to remain the leader in the drug-eluting stent market and we think we are in a good position to do that," says Donovan.

Irish company Clearstream has also recently launched its first drug-coated stent, the Intrepide. While not licensed for the US market, chief executive Andy Jones believes his product has the potential to be a strong player in Europe and elsewhere.

Unlike many of its rivals, the Intrepide does not use a cytotoxic drug. This obviates the need for the long-term use of anticoagulants (anti-clotting drugs) following stent procedures, something that Jones says makes it more appropriate for some patients - especially diabetics and older people - who might need other forms of surgery that would make anticoagulants inappropriate.

"Confidence is slowly re-emerging [after fears of the link between drug-coated stents and clotting that emerged at the European Society of Cardiology 2006 World Congress in Barcelona in 2006]," says Jones. The report knocked close to 50 per cent off what was then a $4 billion (€2.54 billion) industry, but a series of studies have since stressed the continued efficacy of drug-coated stents compared to alternative treatments.

Clearstream's Intrepide won European approval earlier this year.

With the stent market expected to recover to around $5.1 billion this year and demographics in key markets that point to increased demand in the years ahead, all the existing players in the market continue to invest millions in developing the next generation of stent products.

Abbott's Damian Halloran points to ongoing work in the company on a bio-absorbable stent that would dissolve after it had done its work - getting over the concern people understandably have about having bits of metal in and around their heart.

"We are the only company in the world with one-year clinical data on a bio-absorbable stent and it is looking really promising," he said.