Sign in Subscribe
Medical equipment industry

Boston Scientific Receives FDA Approval for ATLAS Clinical Trial of Taxus Liberte Stent System

Strategic Insights

— 1 min read

Boston Scientific 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 for the Taxus Liberte stent system, a next-generation paclitaxel-eluting coronary stent system. The trial is designed to assess the safety and efficacy of the slow-release dose formulation paclitaxel-eluting Taxus Liberte stent system for the treatment of coronary artery disease. The trial is scheduled to enroll 822 patients at 60 sites in the United States, Canada, Australia, New Zealand, Singapore, Hong Kong and Taiwan.

Key Takeaways:

  • Boston Scientific has received FDA approval for the ATLAS clinical trial of its Taxus Liberte stent system, a next-generation paclitaxel-eluting coronary stent system.
  • The ATLAS trial is designed to assess the safety and efficacy of the slow-release dose formulation paclitaxel-eluting Taxus Liberte stent system for the treatment of coronary artery disease.
  • The trial will enroll 822 patients at 60 sites in the United States, Canada, Australia, New Zealand, Singapore, Hong Kong and Taiwan.
  • Keith Dawkins, MD, consultant cardiologist, Wessex Cardiothoracic Centre, Southampton University Hospital, Southampton, England, has expressed enthusiasm for the new stent technology, citing its excellent conformability and deliverability.
  • The Taxus Liberte stent is a next-generation stent designed to further enhance deliverability and conformability, particularly in challenging lesions.
  • The clinical trial is a pivotal study to collect data to support regulatory filings for product commercialization.

Statistics:

  • 822 patients will be enrolled in the ATLAS clinical trial.
  • 60 sites will participate in the trial across the United States, Canada, Australia, New Zealand, Singapore, Hong Kong and Taiwan.
  • The Taxus Liberte stent system is a next-generation paclitaxel-eluting coronary stent system.
  • 2,000 patients have been enrolled in Taxus clinical trials conducted to date.

Sources:

  • [NewsRx.com & NewsRx.net]
  • [Boston Scientific Corp.]
  • [Pharma Business Week]

Read more