Boston Scientific Receives CE Mark for Large Vessel Taxus Stent Sizes

Strategic Insights -

Boston Scientific Corporation has secured CE Mark approval for three large vessel sizes (4.0mm, 4.5mm, and 5.0mm) of its Taxus Express2 paclitaxel-eluting coronary stent system in Europe and other international markets. This move enables the company to offer a full range of stent sizes, addressing the unmet need of patients with large vessels suffering from coronary artery disease. The Taxus stent system is the global market leader in drug-eluting stent systems, having received CE Mark in Europe in January 2003 and U.S. FDA approval in March 2004. With the new large vessel sizes, Boston Scientific aims to provide physicians with a full complement of drug-eluting stent sizes featuring the safety, efficacy, and outstanding deliverability of the Taxus system.

Key Takeaways:

  • Boston Scientific receives CE Mark for three large vessel sizes (4.0mm, 4.5mm, and 5.0mm) of its Taxus Express2 paclitaxel-eluting coronary stent system.
  • The company plans to launch the new sizes immediately, completing its line of stent sizes in Europe and international markets.
  • The largest drug-eluting stent system size previously available was 4.0mm, limiting clinicians' options for treating patients with large vessels.
  • Paul LaViolette, Boston Scientific's chief operating officer, notes that the CE Mark approval for large vessel sizes provides a full complement of drug-eluting stent sizes featuring the safety, efficacy, and outstanding deliverability of the Taxus system.
  • The Taxus stent system is the global market leader in drug-eluting stent systems, having received CE Mark in Europe in January 2003 and U.S. FDA approval in March 2004.
  • Boston Scientific expects to receive FDA approval for its large vessel Taxus stent sizes in the first quarter of 2006.
  • The company has also announced the launch of its Taxus Liberte paclitaxel-eluting stent system in 18 countries in January 2005, featuring its next-generation Liberte coronary stent.

Statistics:

  • Three large vessel sizes (4.0mm, 4.5mm, and 5.0mm) of the Taxus Express2 paclitaxel-eluting coronary stent system have received CE Mark approval.
  • 18 countries have launched the Taxus Liberte paclitaxel-eluting stent system in January 2005.
  • Boston Scientific plans to launch the Taxus Liberte system in Europe later this year and in the United States next year, subject to regulatory approval.
  • The Taxus stent system has received CE Mark in Europe in January 2003 and U.S. FDA approval in March 2004.

Sources:

  • Health & Medicine Week
  • NewsRx.com
  • Boston Scientific Corporation