Another variation from Abbott's Xience stent line wins CE mark

Abbott ($ABT) is mobilizing efforts to start selling its next-generation Xience Xpedition drug-eluting stent in Europe, after winning CE mark status to treat coronary artery disease with the device. Thus begins yet another aggressive marketing push to keep Xience products at the forefront of an extremely crowded marketplace.

Xience Xpedition gained its CE mark, in part, based on data involving 45,000 patients from 100 studies. The company notes those evaluations also include 5 years of long-term outcomes data. And if you want size options, Abbott points out that the product ranges in diameter from 2.25 mm to 4 mm, and can range from 8 mm to 38 mm long. Size matters in the hyper-competitive stent world: Boston Scientific ($BSX) heavily promoted the FDA approval in June of two new lengths of its Promus Element stent, for example, underscoring the competition to convince doctors who has the most drug-eluting stent options.

While Abbott also sells Xience Xpedition in Asia and the Middle East, the product is still being tested in the U.S., where the FDA approval process offers far more obstacles to an industry seeking to reach the market before competitors do.

Abbott continues to move full speed ahead in diversifying its Xience line, and stent product offerings in general. In April, for example, the company gained Japanese approval to use its Xience Prime drug-eluting coronary stent to treat clogged arteries, following U.S. approval last November. Earlier this month the company won a crucial FDA sign-off for its Omnilink Elite vascular balloon-expandable stent system to treat iliac artery disease. Meanwhile, Xience Prime and Xience V are approved for use in the U.S., Europe, the Middle East, Japan and parts of Asia, Abbott explains.

Abbott investors were pretty mellow about the whole thing. Perhaps they were more distracted by news from over the weekend that the SEC indicted a lower-level Abbott executive James Mazzo over alleged insider trading issues regarding Abbott's $2.8 billion acquisition of Advanced Medical Optics back in 2009. The company's stock went up about 8 cents to $66 in early trading on Aug. 20. Coming soon: Abbott will split in two, with the drug division becoming a new entity called AbbVie, as Abbott's medical products division retains the company name.

- read the release
- more on Mazzo from MassDevice

Special Report: Abbott Labs - Top 10 Medical Device R&D Budgets

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