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Medical equipment industry

Boston Scientific Receives FDA Approval for ATLAS Clinical Trial on Taxus Liberte Paclitaxel-Eluting Stent

Strategic Insights

— 1 min read

Boston Scientific Corporation has announced that it has received an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) to begin its ATLAS clinical trial, using the Liberte coronary stent as a platform for its paclitaxel-eluting coronary stent system. The trial aims to assess the safety and efficacy of the Taxus Liberte stent system for the treatment of coronary artery disease. The study will enroll 822 patients at 60 sites in the United States, Canada, Australia, New Zealand, Singapore, Hong Kong, and Taiwan.

Key Takeaways:

  • The ATLAS clinical trial will be a pivotal study to collect data to support regulatory filings for product commercialization of the Taxus Liberte paclitaxel-eluting stent system.
  • The trial will assess the safety and efficacy of the Taxus Liberte stent system for the treatment of coronary artery disease.
  • The study will enroll 822 patients at 60 sites in the United States, Canada, Australia, New Zealand, Singapore, Hong Kong, and Taiwan.
  • Boston Scientific's Liberte stent has been designed to enhance deliverability and conformability, particularly in challenging lesions.
  • The Taxus Liberte stent system will feature the proven efficacy of paclitaxel, together with an outstanding stent and an enhanced delivery system.

Statistics:

  • 822 patients will be enrolled in the ATLAS clinical trial.
  • 60 sites in the United States, Canada, Australia, New Zealand, Singapore, Hong Kong, and Taiwan will participate in the trial.
  • Boston Scientific has shipped more than 500,000 Taxus stent systems and more than 600,000 Express2 stent systems.
  • The company has identified approximately 85,000 taxus stent systems and approximately 11,000 Express2 stent systems that may exhibit characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.
  • The company has received reports of one death and 18 serious injuries associated with balloon deflation for the Taxus stent system, and two deaths and 25 serious injuries associated with balloon deflation in the Express2 (bare metal) stent system.

Sources:

  • Boston Scientific Corporation via NewsRx.com & NewsRx.net on Aug 9, 2004.
  • NewsRx.com & NewsRx.net.

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