Boston Scientific (Natick Massachusetts) is taking a huge leap ahead of the competition with the FDA approval of its Taxus Liberté Atom paclitaxel-eluting coronary stent system. The company said that, with this approval, it has a DES for use in vessels as small as 2.25 mm in diameter – something it says no other company has on the market.

This is the second generation of the Taxus Liberté, which is a little smaller than most of Boston SCi's other DES offerings.

"This is a unique space that we occupy," Jeff Lemaster, VP of Stent Marketing for Boston Scientific, told Medical Device Daily. "No one else offers a DES in this size."

But what does size matter? In this case, almost everything, according to Lemaster. The smaller size reduces the chance of restenosis, a painful side effect that seems to occur after some DES are implanted.

"This is just bettering terms of efficacy and safety," he said.

Last year's launch of the Taxus Express Atom Stent offered an alternative treatment choice for patients with small vessels who will now have the additional option of the Taxus Liberté Atom stent.

Data from numerous clinical studies have shown that an estimated 10% of patients undergoing percutaneous coronary interventions have small vessels (<2.5 mm). Until recently, many physicians were inclined to implant bare-metal stents in these patients since they were the only approved stenting option for small vessels. The only other option was angioplasty.

The Taxus Liberté Stent features design improvements over the company's first-generation Taxus Express Stent, including thinner struts to allow better stent deliverability and conformability, as well as uniform stent geometry for consistent lesion coverage and drug distribution.

On top of being an improvement over past generations, the company said that this product offering will be able to sustain itself and go without much competition from other med-tech companies for quite some time.

Lemaster told MDD that although Medtronic (Minneapolis), Johnson & Johnson (New Brunswick, New Jersey) and Abbott (Abbott Park, Illinois) all had drug-eluting stents, the smallest size that these companies manufactured was 2.5 mm.

"We measure our market share at 6% – there is about another 2% we can glean from the approval of [the Liberte Atom Stent] because nobody can compete in that market. J&J has been trying to get approval for 2.25 mm for two or three years and we've heard nothing further about them pushing such a goal. Abbott is pursuing the 2.25 mm – but we don't anticipate any other company getting clearance for 2.25 mm until about early 2012 or 2013."

That amount of lead time would give Boston Sci a significant amount of time to establish the brand.

Despite published reports attacking the safety and efficacy of DES, Boston Sci said it remains confident that the market is strong for these devices.

The company said on Wednesday that DES as a whole was on an upward swing and that the numbers of patients using DES have increased.

Taxus stents have been evaluated by the industry's most extensive randomized, controlled clinical trial program, Boston Sci said, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries.

To date, nearly 11 million Boston Scientific stents have been implanted globally; making them the world's most frequently used stents.

The company said it expects to expand its stent portfolio later this year with the first 38 mm-long DES, the Taxus Liberté Long Stent, which is under review by the FDA.