Boston Scientific Begins Enrollment in ATLAS Clinical Trial

Strategic Insights -

Boston Scientific Corporation has announced the start of enrollment in the ATLAS clinical trial, marking a significant milestone in the development of its Taxus Liberte paclitaxel-eluting coronary stent system. The trial, which will assess the safety and efficacy of the Liberte stent system, is designed to enroll 822 patients at 60 sites in seven countries, including the United States, Canada, Australia, New Zealand, Singapore, Hong Kong, and Taiwan. The first patient was enrolled at Washington Adventist Hospital in Takoma Park, Maryland, and the company has received approval from the U.S. Food and Drug Administration to begin the trial.

Key Takeaways:

  • The ATLAS trial is a pivotal study designed to collect data to support regulatory filings for the commercialization of the Taxus Liberte paclitaxel-eluting coronary stent system.
  • The Liberte stent system has been designed to enhance deliverability and conformability, particularly in challenging lesions, and will be available in a bare metal version in international markets.
  • The trial will assess the safety and efficacy of a slow-release dose formulation of paclitaxel-eluting Taxus Liberte stent system for the treatment of coronary artery disease.
  • The trial will enroll 822 patients at 60 sites in seven countries, including the United States, Canada, Australia, New Zealand, Singapore, Hong Kong, and Taiwan.
  • The first patient was enrolled at Washington Adventist Hospital in Takoma Park, Maryland, and the company has received approval from the U.S. Food and Drug Administration to begin the trial.
  • Mark A. Turco, MD, FACC, director of the Center for Cardiac and Vascular Research at Washington Adventist Hospital, and co-principal investigator for the ATLAS study, has expressed his enthusiasm for the Liberte stent system, citing its flexibility and maneuverability.

Statistics:

  • 822 patients will be enrolled in the ATLAS trial at 60 sites in seven countries.
  • 60 sites will participate in the trial across seven countries, including the United States, Canada, Australia, New Zealand, Singapore, Hong Kong, and Taiwan.
  • The trial has received approval from the U.S. Food and Drug Administration.
  • The Liberte stent system has been designed to enhance deliverability and conformability in challenging lesions.
  • The trial will assess the safety and efficacy of a slow-release dose formulation of paclitaxel-eluting Taxus Liberte stent system for the treatment of coronary artery disease.

Sources:

  • NewsRx.com & NewsRx.net (http://www.newsrx.com/)
  • Boston Scientific Corporation
  • Washington Adventist Hospital
  • U.S. Food and Drug Administration