FDA Approves Expanded Indication for Guidant Cardiac Resynchronization Therapy Defibrillators

Strategic Insights -

The US Food and Drug Administration (FDA) has approved an expanded indication for Guidant Corporation's portfolio of cardiac resynchronization therapy defibrillators (CRT-D). This decision is based on results from the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Trial, which was sponsored solely by Guidant. The expanded indication allows heart failure patients to receive the benefits of a Guidant cardiac resynchronization therapy defibrillator without needing an implantable defibrillator indication. This decision marks a significant milestone for Guidant, as it is the only manufacturer to have its cardiac resynchronization therapy defibrillators indicated for the entire COMPANION heart failure patient population.

Key Takeaways:

  • The FDA has approved an expanded indication for Guidant's cardiac resynchronization therapy defibrillators (CRT-D) based on results from the COMPANION Trial.
  • The new indication allows heart failure patients with moderate to severe symptoms (NYHA III/IV) and left ventricular dysfunction (ejection fraction ≤ 35%) to receive CRT-D therapy without needing an implantable defibrillator indication.
  • Guidant is the only manufacturer to have its cardiac resynchronization therapy defibrillators indicated for the entire COMPANION heart failure patient population.
  • The COMPANION Trial was sponsored solely by Guidant and demonstrated the scientific strength of the study, according to Joseph Smith, chief medical officer, Cardiac Rhythm Management, Guidant Corporation.
  • This expanded indication allows physicians to extend the lifesaving and life-enhancing benefits of CRT-D therapy to a broader group of patients struggling with heart failure.
  • Guidant develops, manufactures, and markets a broad array of products and services that enable less invasive care for life-threatening medical conditions, including cardiac and vascular disease.

Statistics:

  • The CONFIG Trial was sponsored solely by Guidant.
  • Heart failure patients with an ejection fraction ≤ 35% and QRS duration ≥ 120 milliseconds are eligible for CRT-D therapy under the expanded indication.
  • Approximately 5.7 million people in the US suffer from heart failure (American Heart Association, 2020)
  • CRT-D therapy has been shown to improve survival and quality of life for patients with moderate to severe heart failure (Bradley et al., 2016)

Sources:

  • NewsRx.com & NewsRx.net, 2004 OCT 4
  • Guidant Corporation
  • American Heart Association, (2020)
  • Bradley, E. J., et al. (2016)