Angeion Corporation Receives FDA Approval for Sentinel Implantable Cardioverter Defibrillator System

Strategic Insights -

Angeion Corporation, a leading developer of devices to treat life-threatening heart conditions, has received an investigational device exemption (IDE) from the United States Food and Drug Administration (FDA) to conduct clinical trials of its Sentinel TM 2000 implantable cardioverter defibrillator system in the United States. This approval allows Angeion to proceed with up to 60 implants in 15 centers nationwide, marking a significant milestone in the development and commercialization of the Sentinel system.

Key Takeaways:

  • Angeion Corporation has received an IDE from the FDA to conduct clinical trials of its Sentinel TM 2000 implantable cardioverter defibrillator system in the United States.
  • The IDE enables Angeion to conduct up to 60 implants in 15 centers nationwide, providing a significant opportunity to gather data on the system's performance.
  • The Sentinel system is designed to improve monitoring and therapy while increasing patient comfort, reducing costs, and easing implantation procedures.
  • Angeion has also applied for CE Mark approval, which will allow the company to market the Sentinel system throughout Europe.
  • The Sentinel system is designed to treat life-threatening rapid irregular heartbeats originating in the ventricles, or lower chambers of the heart.
  • Mark Kroll, Ph.D., vice president of research and product planning at Angeion, has joined Pacesetter, Inc., a St. Jude Medical company, to direct the cooperative effort between the two companies.

Statistics:

  • Up to 60 implants will be conducted in the United States.
  • The clinical trials will take place in up to 15 centers nationwide.
  • The Sentinel system is designed to treat life-threatening rapid irregular heartbeats originating in the ventricles, or lower chambers of the heart.
  • Angeion has already initiated clinical trials of the Sentinel 2000 in Europe, where implants have begun in Germany, Italy, and the United Kingdom.
  • The CE Mark approval will enable Angeion to market the Sentinel system throughout Europe.

Sources:

  • PRNewswire, "Angeion Corporation Receives FDA Approval for Sentinel Implantable Cardioverter Defibrillator System" (October 31, 1995)
  • Angeion Corporation, press release (October 31, 1995)