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Guidant Announces Enrollment of First Patient in Innovative Atrial Fibrillation Trial

Strategic Insights

— 1 min read

Guidant Corporation, a pioneer in lifesaving technology, has announced the enrollment of the first patient in a clinical trial designed to study a novel therapy for the treatment of permanent atrial fibrillation. The randomized trial, called RESOLVE-AF, will evaluate the safety and efficacy of Guidant's FLEX Microwave Surgical Ablation System in treating patients with permanent atrial fibrillation undergoing mitral valve surgery. The trial aims to enroll 200 patients at up to 40 U.S. and European centers.

Key Takeaways:

  • The RESOLVE-AF trial is a prospective, randomized study that will evaluate the safety and efficacy of Guidant's FLEX Microwave Surgical Ablation System in treating patients with permanent atrial fibrillation undergoing mitral valve surgery.
  • The trial will enroll 200 patients at up to 40 U.S. and European centers, with the goal of obtaining U.S. Food and Drug Administration (FDA) approval to treat permanent atrial fibrillation with the technology.
  • The study is significant, as atrial fibrillation affects as many as two-thirds of all atrial fibrillation patients, and can cause heart failure, reduced quality of life, higher medical costs, and a five-fold increase in the risk of stroke.
  • Guidant's FLEX Microwave Surgical Ablation System has been used in over 8,000 procedures worldwide and has received CE Mark approval in Europe specifically for the treatment of atrial fibrillation.
  • The company's commitment to atrial fibrillation therapy is demonstrated through its sponsorship of the RESOLVE-AF trial and its development of treatments for this debilitating condition.
  • The trial's principal investigator, Michael J. Mack, M.D., is enthusiastic about the potential of this therapy, which may help expand the treatment options for patients suffering from atrial fibrillation.

Statistics:

*Approximately 2.4 million patients in the United States suffer from atrial fibrillation, and its prevalence is expected to double in the next 40 years.

  • In approximately 50 percent of atrial fibrillation patients, drug therapy is ineffective or causes severe side effects.
  • Guidant's FLEX Microwave Surgical Ablation System has been used in over 8,000 procedures worldwide.
  • The study aims to enroll 200 patients at up to 40 U.S. and European centers.

Sources:

  • Guidant Corporation (NYSE: GDT)
  • John Johnkoski, M.D., cardiothoracic surgeon, at Wausau Hospital in Wausau, Wis.
  • Maria Degois-Sainz, president, Cardiac Surgery, Guidant Corporation
  • Michael J. Mack, M.D., director of Transplantation, Medical City Dallas Hospital, Dallas, Texas, cardiovascular/thoracic surgeon and principle investigator of the trial
  • Guidant Corporation news release, June 27, 2005.

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